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Algernon Pharmaceuticals Hits Co-Primary Endpoint in its Phase 2 Study of Ifenprodil for Idiopathic Pulmonary Fibrosis and Chronic Cough

Algernon Pharmaceuticals Hits Co-Primary Endpoint in its Phase 2 Study of Ifenprodil for Idiopathic Pulmonary Fibrosis and Chronic Cough

VANCOUVER, British Columbia, July 18, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage Canadian pharmaceutical development company, is pleased to announce positive topline data showing that it has met the co-primary endpoint in its Phase 2 proof of concept study evaluating NP-120 (“Ifenprodil”) for the potential treatment of idiopathic pulmonary fibrosis (“IPF”) and chronic cough. In the study, 65% of patients had stable or improved forced vital capacity (“FVC”) over the 12-week treatment period with statistical significance when compared to an anticipated placebo effect of 40%. FVC is the amount of air that can be forcibly exhaled from one’s lungs after taking the deepest breath possible.

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B), which prevents glutamate signalling. Ifenprodil represents a novel first in class treatment for both IPF and chronic cough.

IPF Data Set

To understand the potential efficacy for Ifenprodil in IPF patients, lung function in this trial was measured by FVC (a best-efforts measurement) which was taken for each patient at baseline, and then again at 12 weeks. Patients whose FVC declined were classified as non-responders, while those whose FVC improved or remained stable were classified as responders. The primary endpoint of the IPF part of the study was the proportion of patients who responded.

Of the 20 patients who enrolled, 13 (65%) had stable or improved FVC over the 12-week treatment period with statistical significance when compared to an anticipated placebo effect of 40% (p=.0225, 95% CI 40.8 to 84.6%, all numbers are Intent-to-Treat analysis). Importantly, key opinion leaders advising the company, as well as historical data on previously conducted IPF clinical studies(1), indicated that approximately 30-40% of IPF patients would experience no decline in FVC if they were dosed with a placebo over the 12-week period, demonstrating that Ifenprodil showed promising initial IPF efficacy in this trial.

The Company also reports trends to reduction in many of the serum markers that were tested including proC3, C3M, C6M, reC1M, proC8 and ELP-3, although the data did not reach statistical significance. Elevation of these markers has been associated with increased mortality and risk of disease progression in previous research studies.

“The IPF data looks quite good,” said Dr. Martin Kolb, professor of respirology at McMaster University and global expert on IPF. “I was very surprised to see the data achieve statistical significance with such a small study size, when you consider the original goal of the study was to try to identify a signal. As a result, I am confident that the Company should begin planning a sufficiently powered Phase 2b study to investigate Ifenprodil as a possible new treatment for IPF patients, including those who have associated cough.”

Chronic Cough Data Set

For the chronic cough part of the study’s primary endpoint, 30% of subjects achieved the endpoint of a 50% reduction in the average number of coughs per hour over 24 hours from baseline to week 12. While this primary cough study endpoint did not achieve statistical significance when compared to an anticipated placebo effect of 25%, the secondary endpoint of actual changes (reduction) in cough counts did. Specifically, subjects experienced a 24% relative reduction from baseline in mean cough count, and a 38% relative reduction from baseline in median cough count in their 24-hour cough count per hour at week 12 (p=0.0344). In addition, 75% of subjects saw improvements in their cough over 12 weeks.

This data shows that while Ifenprodil didn’t achieve the more stringent primary endpoint parameter on cough, there is a definite signal (effect) when comparing cough counts directly to their baseline measurement. Furthermore, in contrast with recent studies on cough drugs targeting purinergic receptors, the observed effect may not be dependent on a subject’s baseline cough count; in a subgroup analysis, subjects with baseline cough counts below the median for the study appeared to achieve similar reductions in relative cough count to those with baseline counts above the median.

“These data are quite compelling,” said Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester, and an Honorary Consultant at Manchester University NHS Foundation Trust. “Although the primary cough endpoint does not reach statistical significance, the reductions in cough counts, particularly the median cough counts, are suggestive of a beneficial effect. Furthermore, the choice of a 25% response rate as a comparator may understate the benefit. Existing IPF therapies have little to no effect on cough, and so coupled with the results in IPF seen in this trial, there is great reason for optimism. I am working with the Company to further analyze the data and encourage them to continue to study the effects on cough as development of this drug continues.”

Safety Data

The results also show that Ifenprodil’s safety profile in this trial was consistent with findings from previous studies of the drug, with no new safety signals observed. 45% of subjects experienced at least one treatment-emergent adverse events (TEAE), most of which were mild in intensity. The most common TEAE’s were gastrointestinal disorders (25%) and decreased appetite (10%). One participant withdrew from the study due to a hepatic neuroendocrine tumour unrelated to Ifenprodil, that resulted in death. Although Ifenprodil has been used in Japan for decades to treat vertigo, this is the first study in an IPF population, and so the Company is pleased to report that no new safety concerns were identified.

Full Data Set

The Company expects to receive the full data set from the study in August 2022 and will present the full results of the study at the 21st International Colloquium on Lung and Airway Fibrosis in Reykjavik, Iceland in October 2022.

“Simply put, the IPF data is better than we could have imagined,” said Christopher J. Moreau, CEO of Algernon. “The outlook for patients with IPF remains dismal, with 50% mortality expected within 3-4 years and new drugs are desperately needed. Also, the IPF market size is projected to reach $4.2 billion by 2030(2), so it is a very commercially appealing indication to be advancing a new drug for. While the cough data is also promising, we will wait until we have the full data set before making any final decisions on pursuing both IPF and chronic cough in separate Phase 2b clinical studies, or focussing on just IPF patients with associated cough.”

U.S FDA pre-IND

Based on the positive data, the Company plans to file a pre-IND application with the U.S. FDA for a Phase 2b IPF study. The current plan would be to switch to a new once-a-day formulation of Ifenprodil from the 3-times daily dosing currently being used. The Phase 2b study will also have multiple arms, multiple doses, would be placebo controlled and would be double blinded and randomized.

For chronic cough, the Company has already filed a pre-IND application with the U.S. FDA and has announced that it has received positive feedback.

The Company will take additional time to review the full data set before a decision is made to pursue an independent Phase 2b study of chronic cough or to focus on Ifenprodil as a potential new IPF drug that also reduces cough for those patients that are suffering from both.

U.S Orphan Indication and Breakthrough Therapy

IPF is also classified as an orphan disease indication and as such, any new approved drugs are provided 7-year and 10-year market exclusivity in both the U.S and Europe, respectively. The Company plans to file for an orphan designation with the U.S FDA for Ifenprodil and IPF shortly.

The Company plans to file an application with the U.S. FDA for a Breakthrough Therapy designation as soon as possible.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Ifenprodil Patents

The Company also recently announced that it has been issued a patent from the Canadian Intellectual Property Office, No. 3101853, for the treatment of interstitial lung disease with Ifenprodil, entitled “Compositions and Methods for Treating Idiopathic Pulmonary Fibrosis.”

The invention claims treating interstitial lung disease, including IPF, with Ifenprodil. The base claims of the patent will be valid through 2040, excluding any patent term adjustments or extensions which may provide additional protection. The Company also has active patent applications for Ifenprodil for the same compositions and methods in the U.S., Europe, China and Japan.

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

      https://erj.ersjournals.com/content/55/5/1902151(1)   
      https://www.astuteanalytica.com/industry-report/idiopathic-pulmonary-fibrosis-market(2)   

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulators. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Algernon Pharmaceuticals Provides Update on Its Phase 1 DMT Stroke Study

Algernon Pharmaceuticals Provides Update on Its Phase 1 DMT Stroke Study

VANCOUVER, British Columbia, July 07, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a clinical stage Canadian pharmaceutical development company, is pleased to provide an update on its planned Phase 1 clinical human study of AP-188 (“N,N-dimethyltryptamine” or “DMT”). DMT is a known psychedelic compound that is part of the tryptamine family.

The Company is currently working to complete the intravenous formulation (“IVF”) that will be used in the Phase 1 DMT study and has retained the Centre for Human Drug Research (“CHDR”) and its affiliated pharmacy at the Leiden University Medical Center in the Netherlands, to complete the work. The Company is planning to begin the Phase 1 study in September of 2022.

The Company announced earlier that it had filed for a Clinical Trials of Investigational Medicinal Products (“CTIMP”) application with the United Kingdom Medicines and Healthcare Products Regulatory Agency (“UK MHRA”) via the combined review service, which provides for a single application route for both clinical trial authorization and ethics approval. The key feedback provided by the UK MHRA focussed on the IVF of DMT for administration.

The original plan was to complete the IVF in the onsite pharmacy at Hammersmith Medicines Research (HMR) in London, prior to the Phase 1 DMT study beginning. However, to meet the specifications requested by the UK MHRA, it was determined that a new vendor would be needed that had additional technical cGMP-suite capabilities.

After working to identify qualified vendors that could perform the needed work in the required time period, the Company selected CHDR and the IVF work is in progress.  In addition to its fill finish cGMP-suite services, CHDR is also a world class clinical trial center, performing approximately 60 early-phase clinical studies per year.

The primary focus of Algernon’s planned Phase 1 DMT study is to investigate prolonged intravenous infusion of DMT, for durations which have never been clinically studied. The resulting data generated will help the Company to plan both its Phase 2 acute stroke and rehabilitation studies more effectively.

Phase 1 DMT Stroke Study Summary

The purpose of the planned study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion. The first part of the study will use a single-escalating dose design while the second part will test the effects of repeated administrations of the highest safe dose. There will be up to 60 healthy volunteers enrolled across the two parts of the study which will include both psychedelic experienced and psychedelic naïve patients.

About DMT

N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin. DMT can also be synthesised in a laboratory.

Algernon has filed provisional patents for new salt forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke. The Company has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Algernon Pharmaceuticals Discloses Novel DMT Salt Patent Strategy Includes Bioactive Nicotinate and Pamoate

Algernon Pharmaceuticals Discloses Novel DMT Salt Patent Strategy Includes Bioactive Nicotinate and Pamoate

VANCOUVER, British Columbia, July 05, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to disclose that as part of its intellectual property patent applications filed in early 2021 for AP-188 (“N,N-dimethyltryptamine” or “DMT”), the Company included nicotinate and pamoate as novel salt forms of DMT. Nicotinate and pamoate are commonly used counterions when producing salts.

A novel salt form of a drug is a new and separate structure from the original compound and is considered a new composition of matter, anchoring the Company’s novel patent filings. Many drug compounds’ core structures can be paired with another compound to form a salt. Different salts can improve the core drug in several ways, including improved efficacy, safety/tolerability, and stability.

The Company also announces that in its own binding study of nicotinate and pamoate, the salts showed, when compared to fumarate, the most studied form of DMT, that they had similar binding to the 5-HT2A and sigma-1 receptors; key receptors in the brain that are activated by DMT.

In addition to improved physicochemical properties, nicotinate and pamoate are not inert, but in fact have shown neuronal activity independent of DMT and may assist with the efficacy of DMT as a potential treatment for stroke.

In a mouse model of ischemic stroke, pamoate (in the form of pamoic acid) alone displayed neuroprotective effects including reduced infarct volume, oxidative stress and iron deposition, as well as improved motor function compared to vehicle controls. Benefits were seen even when treatment was delayed by one hour.1 STUDY 1

Nicotinate (in the form of nicotinic acid or niacin) is a form of vitamin B3 and is an essential nutrient. In a rat stroke model, nicotinic acid alone significantly increased markers of neuroplasticity, and complementary in vitro studies showed an increase in BDNF/Trk-B expression.2 STUDY 2

Furthermore, in another rat stoke study, niacin alone was able to improve functional recovery even when treatment is started 24 hours after the occurrence of the occlusion and there is no significant difference in lesion volume.3 STUDY 3

The Company believes that it has maximized its intellectual property position around DMT, which includes filing patent applications for new novel bioactive salt forms, as outlined herein, as well as dosing, formulation, and method of use patent applications for stroke rehabilitation.

“Shortly after filing our PCT application, we received a Written Opinion from the International Searching Authority that DMT nicotinate and DMT pamoate are novel and non-obvious, and appear to be patentable,” said Christopher J. Moreau, CEO of Algernon. “Since DMT on its own is naturally occurring and is therefore unpatentable as a new chemical entity, Algernon’s strategy is to ensure that along with trying to achieve good clinical data, the Company has a correspondingly strong intellectual property position that is unique and protectable.”

About DMT

N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin. DMT can also be synthesised in a laboratory.

Several preclinical studies have demonstrated that DMT helps mitigate tissue damage and promote neurogenesis as well as structural and functional neural plasticity, with significance. These are key factors involved in the brain’s ability to form and reorganize synaptic connections, which are needed for healing following a brain injury.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

1. Sharmin O, Haque Abir A, Potol A, Alam M, Banik J, Towheedur Rahman AFM, Tarannum N, Wadud R, Farhad Habib Z, Rahman M. Scientific Reports 10, 9400 (2020).

2. Cui, X, Chopp M, Zacharek A, Roberts C, Buller B, Ion M, Chen J. Stroke 41(9), 2044 (2010).

3. Chen J, Cui X, Zacharek A, Jiang H, Roberts C, Zhang C, Lu M, Kapke A, Feldkamp CS, Chopp M. Annals of Neurology 62(1), 49 (2007).

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Algernon Pharmaceuticals Announces Closing of Public Offering of Units

Algernon Pharmaceuticals Announces Closing of Public Offering of Units

July 04, 2022 11:14 ET | Source: Algernon Pharmaceuticals

VANCOUVER, British Columbia, July 04, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) is pleased to announce the closing of its previously announced marketed public offering of units of the Company (the “Units” or the “Offered Securities”) with Research Capital Corporation as the sole agent and sole bookrunner (the “Agent”). Pursuant to the offering, the Company issued 309,117 Units at a price of $3.75 per Unit for gross proceeds of $1,159,188.75 (the “Offering”).

Each Unit consists of one Class A common share of the Company (a “Common Share“) and one Common Share purchase warrant of the Company (a “Warrant“).

Each Warrant entitles the holder thereof, subject to adjustment in certain circumstances, to purchase one Common Share (a “Warrant Share”) at an exercise price equal to $4.70 per Warrant Share (the “Warrant Exercise Price”) for a period of 5 years following the date of issuance (the “Expiry Date”), subject to acceleration of the Expiry Date as described below.

In the event of a down-round financing during the period of 5 years following closing of the Offering (a “Dilutive Issuance”), the Warrants contain an anti-dilution protection feature, to adjust the Warrant Exercise Price and increase the number of Warrant Shares issuable thereunder if Common Shares are sold or issued for a consideration per share less than the Warrant Exercise Price (subject to certain exemptions), provided, that the exercise price will not be less than $1.875 (the “Floor Price”).

Provided that if, at any time prior to the expiry date of the Warrants, the volume weighted average trading price of the Common Shares on the CSE, or other principal exchange on which the Common Shares are listed, is greater than $14.10 for 20 consecutive trading days, the Company may, within 10 business days of the occurrence of such event, deliver a notice to the holders of Warrants accelerating the Expiry Date of the Warrants to the date that is not less than 30 days following the date of such notice and the issuance of a press release by the Company announcing the acceleration notice (the “Accelerated Exercise Period”). Any unexercised Warrants shall automatically expire at the end of the Accelerated Exercise Period.

The net proceeds from the Offering of the Units will be used to fund research and development programs, general and administrative expenses and for working capital purposes.

The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such securities may not be offered or sold within the United States or to, or for the account or benefit of, “U.S. persons” (as defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Algernon Pharmaceuticals Inc.

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed intellectual property rights globally for Ifenprodil for the treatment of respiratory diseases.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

Forward-looking statements
This news release contains certain statements which constitute forward-looking statements or information under applicable Canadian securities laws, including statements relating to the expected use of proceeds from the Offering. Such forward-looking statements are subject to numerous known and unknown risks, uncertainties and other factors, some of which are beyond the Company’s control, which could cause actual results or events to differ materially from those stated, anticipated or implied in the forward-looking statements. Although the Company believes that the forward-looking statements in this news release are reasonable, they are based on factors and assumptions, based on currently available information, concerning future events, which may prove to be inaccurate. As such, readers are cautioned not to place undue reliance on the forward-looking statements, as no assurance can be provided as to future plans, operations, results, levels of activity or achievements. The forward-looking statements contained in this news release are made as of the date of this news release and, except as required by applicable law, the Company does not undertake any obligation to publicly update or to revise any of the forward-looking statements, whether as a result of new information, future events or otherwise.

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Algernon Pharmaceuticals Announces Pricing of Public Offering of Units

Algernon Pharmaceuticals Announces Pricing of Public Offering of Units

June 27, 2022 07:00 ET | Source: Algernon Pharmaceuticals

VANCOUVER, British Columbia, June 27, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) is pleased to announce the price of its previously announced marketed public offering of units of the Company (the “Units” or the “Offered Securities”) with Research Capital Corporation as the sole agent and sole bookrunner (the “Agent”), in each of the provinces of Canada (other than Quebec) (the “Offering”). Pursuant to the Offering, the Company intends to issue up to 533,333 Units at a price of $3.75 per Unit for aggregate gross proceeds of up to $2,000,000.

Each Unit will consist of one Class A common share of the Company (a “Common Share“) and one Common Share purchase warrant of the Company (a “Warrant“).

Each Warrant entitles the holder thereof to purchase one Common Share (a “Warrant Share”) at an exercise price equal to $4.70 per Warrant Share (the “Warrant Exercise Price”) for a period of 5 years following the date of issuance.

The Company will use its commercially reasonable efforts to obtain Canadian Securities Exchange (“CSE”) approval to permit the following anti-dilution protection feature of the Warrants. In the event of a down-round financing during the period of 5 years following closing of the Offering (a “Dilutive Issuance”), the Warrants contain an anti-dilution protection feature, to adjust the Warrant Exercise Price and increase the number of Warrant Shares issuable thereunder if Common Shares are sold or issued for a consideration per share less than the Warrant Exercise Price (subject to certain exemptions), provided, that the exercise price will not be less than 50% of the public offering price per Unit (the “Floor Price”).

Provided that if, at any time prior to the expiry date of the Warrants, the volume weighted average trading price of the Common Shares on the CSE, or other principal exchange on which the Common Shares are listed, is greater than $14.10 for 20 consecutive trading days, the Company may, within 10 business days of the occurrence of such event, deliver a notice to the holders of Warrants accelerating the expiry date of the Warrants to the date that is 30 days following the date of such notice (the “Accelerated Exercise Period”). Any unexercised Warrants shall automatically expire at the end of the Accelerated Exercise Period.

The Company will grant to the Agent an option (the “Over-Allotment Option”) to increase the size of the Offering by up to an additional number of Units, and/or the components thereof, that in aggregate would be equal to 15% of the total number of the Offered Securities to be issued under the Offering, to cover over-allotments, if any, and for market stabilization purposes, exercisable at any time and from time to time up to 30 days following the closing of the Offering.

The net proceeds from the Offering of the Units will be used to fund research and development programs, general and administrative expenses and for working capital purposes.

The closing of the Offering is expected to occur on or about July 4, 2022, or on such date as agreed upon between the Company and the Agent. The Company will obtain the necessary approvals to list the Common Shares comprised in the Units, as well as Warrant Shares and the Common Shares issuable upon exercise of compensation warrants, for trading on the CSE.

In connection with the Offering, the Company intends to file a prospectus supplement (the “Supplement“) to the Company’s short form base shelf prospectus dated May 5, 2021 (the “Shelf Prospectus“), with the securities regulatory authorities in each of the provinces of Canada. Copies of the Shelf Prospectus and after it is filed, the Supplement to be filed in connection with the Offering, can be found on SEDAR at www.sedar.com. The Shelf Prospectus contains, and the Supplement will contain, important detailed information about the Company and the Offering. Prospective investors should read the Supplement and accompanying Shelf Prospectus and the other documents the Company has filed on SEDAR at www.sedar.com before making an investment decision.  

The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such securities may not be offered or sold within the United States or to, or for the account or benefit of, “U.S. persons” (as defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. The securities may be offered and sold by way of private placement in the United States and to, or for the account or benefit of “U.S. persons” (as defined in Regulation S under the U.S. Securities Act) pursuant to an exemption from the registration requirements under the U.S. Securities Act, and pursuant to the applicable securities laws of any state of the United States. Any securities offered and sold in the United States shall be issued as “restricted securities” as defined in Rule 144(a)(3) under the U.S. Securities Act. The securities may also be sold in such other jurisdictions as the Company and the Agent may agree. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Algernon Pharmaceuticals Inc.

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements
This news release contains certain statements which constitute forward-looking statements or information under applicable Canadian securities laws, including statements relating to the expected size and pricing of the Offering and the Offered Securities, the terms of the Offered Securities, the anticipated timing of closing the Offering, the ability of the Company to satisfy all conditions to closing the Offering, the expected use of proceeds from the Offering, the Warrants containing an anti-dilution protection feature, the listing of the Warrants on the CSE, the gross proceeds of the Offering and the use of such proceeds. Such forward-looking statements are subject to numerous known and unknown risks, uncertainties and other factors, some of which are beyond the Company’s control, which could cause actual results or events to differ materially from those stated, anticipated or implied in the forward-looking statements. These risks and uncertainties include general economic and capital markets conditions, stock market volatility, the ability of the Company to obtain necessary consents for the Offering, including the approval of the CSE, and the ability of the Company to complete the Offering on the terms expected or at all. Although the Company believes that the forward-looking statements in this news release are reasonable, they are based on factors and assumptions, based on currently available information, concerning future events, which may prove to be inaccurate. As such, readers are cautioned not to place undue reliance on the forward-looking statements, as no assurance can be provided as to future plans, operations, results, levels of activity or achievements. The forward-looking statements contained in this news release are made as of the date of this news release and, except as required by applicable law, the Company does not undertake any obligation to publicly update or to revise any of the forward-looking statements, whether as a result of new information, future events or otherwise.

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Algernon Pharmaceuticals Announces Database Lock in Phase 2 Study of IPF and Chronic Cough

Algernon Pharmaceuticals Announces Database Lock in Phase 2 Study of IPF and Chronic Cough

VANCOUVER, British Columbia, June 13, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that its Phase 2 proof-of-concept study of NP-120 (“Ifenprodil”) for idiopathic pulmonary fibrosis (“IPF”) and chronic cough has reached database lock. This means that all data from the trial is now finally reported, cleaned and “locked” in the database. As previously stated, the Company is projecting that topline data will be available in July, 2022.

The study began in 2020, and recruited patients in Australia and New Zealand with an established diagnosis of IPF and a persistent cough. Recruitment ended in February, 2022, when 20 patients had been enrolled.

Phase 2 Study Summary

The purpose of this proof-of-concept Phase 2 human trial is to determine the safety and efficacy of Ifenprodil in patients with IPF and its associated cough.

In this open label, single-arm study, 20 patients were enrolled that had a diagnosis of IPF and a self-described moderate or worse cough (a score of >40mm on a cough visual analogue scale). Patients were treated with Ifenprodil (20 mg TID) for 12 weeks.

The primary endpoint of the IPF portion of the study is the proportion of patients who achieve zero reduction in lung function at 12 weeks vs. baseline. Lung function was measured by forced vital capacity (“FVC”).

The primary endpoint of the chronic cough portion of the study is a 50% reduction in average 24-hour cough count at 12 weeks vs. baseline. Cough counts were recorded using an ambulatory cough monitor.

However, based on data seen in recent IPF and chronic cough trials from other companies, Algernon will also perform a pre-specified subgroup analysis on patients with higher baseline cough counts. In addition, the Company will also measure the proportion of patients with a less than 2.5% reduction in FVC.

In addition to safety and tolerability, the effect on serum biomarkers of fibrosis will also be reported including proC3, C3M, proC5, C5M, proC6, C6M and reC1M.

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed intellectual property rights globally for Ifenprodil for the treatment of respiratory diseases.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulators. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Algernon Pharmaceuticals Announces Last Patient Treated in Phase 2 Study of IPF and Chronic Cough

Algernon Pharmaceuticals Announces Last Patient Treated in Phase 2 Study of IPF and Chronic Cough

VANCOUVER, British Columbia, May 05, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that the last patient has completed the treatment period in its Phase 2 proof of concept study of NP-120 (“Ifenprodil”) for idiopathic pulmonary fibrosis (“IPF”) and chronic cough.

The Company is projecting that topline data will be available in July 2022.

“We are pleased to be coming closer to this value inflection point in our Phase 2 clinical trial for IPF and chronic cough, both debilitating conditions with limited treatment options,” said Christopher J. Moreau, CEO of Algernon. “We believe Ifenprodil has a unique mechanism of action when compared to the current standard of care for IPF and the drugs in development for chronic cough.”

Phase 2 Study Summary:

The purpose of this proof-of-concept Phase 2 human trial is to determine the safety and efficacy of Ifenprodil in patients with IPF and its associated cough.

In this open label, single-arm study, 20 patients were enrolled that had a diagnosis of IPF and a self-described moderate or worse cough (a score of >40mm on a cough visual analogue scale). Patients were treated with Ifenprodil (20 mg TID) for 12 weeks.

The primary endpoint of the IPF part of the study is the proportion of patients who achieve zero reduction in lung function at 12 weeks vs. baseline. Lung function was measured by forced vital capacity (“FVC”).

The primary endpoint for the chronic cough portion of the study is a 50% reduction in average 24-hour cough count at 12 weeks vs. baseline. Cough counts were recorded using an ambulatory cough monitor.

However, based on data seen in recent IPF and chronic cough trials from other companies, Algernon will also perform a pre-specified subgroup analysis on patients with higher baseline cough counts. In addition, the Company will also measure the proportion of patients with a less than 2.5% reduction in FVC.

In addition to safety and tolerability, the effect on serum biomarkers of fibrosis will also be reported including proC3, C3M, proC5, C5M, proC6, C6M and reC1M.

“Despite recent advances in the treatment of IPF, its prognosis remains dismal, with 50% mortality expected within 3-4 years,” said Dr. Martin Kolb, professor of respirology at McMaster University and Algernon medical consultant. “New treatment options are needed, and I look forward to seeing the results of Algernon’s proof of concept Phase 2 trial.”

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed intellectual property rights globally for Ifenprodil for the treatment of respiratory diseases.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulators. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Algernon Pharmaceuticals Announces Lead Chronic Kidney Disease Drug Repirinast Reduced Fibrosis by 56% in a Preclinical NASH Study

Algernon Pharmaceuticals Announces Lead Chronic Kidney Disease Drug Repirinast Reduced Fibrosis by 56% in a Preclinical NASH Study

VANCOUVER, British Columbia, April 26, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that its lead chronic kidney disease (“CKD”) drug NP-251 (“Repirinast”), reduced fibrosis by 56% with statistical significance, in a preclinical study investigating non-alcoholic steatohepatitis (“NASH”) in the STAM™ mouse model from SMC Laboratories (Japan).

Repirinast was one of multiple drugs that Algernon screened in a NASH preclinical animal study where liver tissue samples from the Repirinast treatment group underwent a pathology review using sirius red staining. The tissue analysis showed that when compared to the negative control group, Repirinast (60mg/kg QD) reduced fibrosis by 56% (p<0.0001).

The Company earlier reported, using the naming protocol NP-251, that Repirinast (30 mg/kg, TID) also reduced fibrosis by 51% vs. untreated controls (p=0.021) in its preclinical animal study of idiopathic pulmonary fibrosis (“IPF”). In the same study, Ifenprodil (4 mg/kg, TID) showed a 56% reduction in fibrosis vs. untreated controls (p=0.015).

Fibrotic disease is a major health problem worldwide. As the common pathological pathway to organ injury and failure, fibrosis usually represents an unsatisfactory prognosis. It is a major cause of death globally and causes substantial medical and economic burdens.1

“When you include the CKD data, Repirinast has shown in three separate preclinical studies, that it has reduced fibrosis in three major fibrotic diseases involving three separate major human organs, all with statistical significance,” said Christopher J. Moreau, CEO of Algernon. “This data suggests that Repirinast has the potential to be an anti-fibrotic compound in multiple indications and so we look forward to advancing it into the planned Phase 1 study.”

About Repirinast

Repirinast was developed by Mitsubishi Tanabe Pharma and was sold and marketed in Japan under the brand name Romet™ for the treatment of asthma. Romet™ was marketed for over 25 years in Japan and has a well-established safety history. The drug acts on mast cells and inhibits the release of chemical mediators by IgE-related antigen antibody interactions.

Intellectual Property

Algernon has filed intellectual property rights globally for Repirinast for the treatment of CKD including dosing and combination with several cholesterol-lowering or antihypertensive drugs. The Company has also filed intellectual property rights globally for Repirinast for the treatment of IPF and NASH.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

(1) https://www.nature.com/articles/s41420-020-00316-9


CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulators. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Algernon Pharmaceuticals Announces Completion of Enrollment in its Phase 2 Study of Ifenprodil for IPF and Chronic Cough

Algernon Pharmaceuticals Announces Completion of Enrollment in its Phase 2 Study of Ifenprodil for IPF and Chronic Cough

VANCOUVER, British Columbia, Feb. 04, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF) a clinical stage pharmaceutical development company, is pleased to announce that it has completed enrollment in its Phase 2 NP-120 (“Ifenprodil”) idiopathic pulmonary fibrosis (“IPF’) and chronic cough study. The Company is projecting a data readout in calendar Q2, 2022.

“We are very pleased to announce this update to the market on our IPF and chronic cough study and we look forward to having it completed and presenting the data,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals.

Phase 2 IPF & Chronic Cough Study Summary

The purpose of this proof-of-concept open label 20 patient Phase 2 human trial is to determine the efficacy of Ifenprodil in the preservation of lung function in IPF patients (including biomarkers of fibrosis) and its associated cough. There are 7 sites in total participating in the study with 5 located in Australia and 2 in New Zealand.

Ifenprodil has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a mouse model of IPF. In addition, Ifenprodil significantly both reduced cough frequency and delayed onset in a guinea pig acute cough model.

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils and certain types of cancer cells.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

Posted on

Algernon Pharmaceuticals Begins Manufacturing of Repirinast and Launches New Chronic Kidney Disease Research Program

Algernon Pharmaceuticals Begins Manufacturing of Repirinast and Launches New Chronic Kidney Disease Research Program

VANCOUVER, British Columbia, Feb. 23, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that it has awarded a contract to Zhejiang Ausun Pharmaceutical CO, LTD of China to begin the manufacturing of a cGMP supply of its repurposed drug candidate NP-251 (“Repirinast”) and has initiated a new chronic kidney disease (“CKD”) research program.

Repirinast was originally developed by Mitsubishi Tanabe Pharma (“Mitsubishi”) and was sold and marketed in Japan under the brand name Romet™ for the treatment of asthma. Romet™ was marketed for over 25 years in Japan. Mitsubishi discontinued manufacturing and sales of the drug in 2013.

Repirinast was approved in Japan for patients with bronchial asthma in 1987, to prevent attacks when administered regularly. A pediatric formulation was also approved in 1990. Unlike most allergy medications, Repirinast does not have a direct antihistaminic effect. The drug acts on mast cells and inhibits the release of chemical mediators by IgE-related antigen antibody interactions.

Repirinast is one of several repurposed drug candidates that were part of Algernon’s acquisition of NASH Pharmaceuticals Inc. (“NASH”) on October 22, 2018.

Repirinast, in a unilateral ureteral obstruction (UUO) mouse model of kidney fibrosis conducted by NASH, reduced fibrosis by 50% with statistical significance. It also showed a modest, but significant, synergistic improvement in combination with telmisartan, which is a blood pressure lowering medication and is considered a front line standard of care treatment for CKD. As part of the new CKD research program, the Company will also investigate the use of Repirinast in acute interstitial nephritis.

“Current treatment of CKD usually consists of measures to help control signs and symptoms, reduce complications, and slow progression of the disease, but there is no cure and new treatment options are needed,” said Christopher J. Moreau, CEO of Algernon. “The pre-clinical data is showing that Repirinast may represent a promising new potential therapy and we look forward to advancing it as quickly as possible into human trials.”

Preclinical Data

Data from the 2019 UUO study demonstrated that clinically relevant doses resulted in statistically significant improvements in the reduction in fibrosis as measured by Sirius Red staining over untreated controls:

  • Telmisartan (3 mg/kg), a positive control, reduced fibrosis by 32.6% (p<0.001)
  • Cenicriviroc (40 mg/kg) a CCR2/5 chemokine receptor antagonist with reported anti-fibrotic activity, reduced fibrosis by 31.9% (p=0.00032).
  • Repirinast (90 mg/kg) reduced fibrosis by 50.6% (p<0.000001).
  • Repirinast (30 mg/kg) reduced fibrosis by 20.8% (p>0.05).
  • The combination of Repirinast (30 mg/kg) and telmisartan (3 mg/kg) reduced fibrosis by 54.2% (p<0.000001). In addition, the mass of the fibrotic kidney was lower than the negative control (p<0.001).

About Chronic Kidney Disease (“CKD”)

CKD is a condition in which the kidneys are damaged or cannot filter blood as well as healthy kidneys, often because of fibrosis. As a result, excess fluid and waste from the blood remain in the body and may cause other health problems.

While there is no known cure, kidney disease complications can be controlled to make patients more comfortable. Treatments are focussed on managing symptoms and complications that include high blood pressure, swelling and anemia.

The global market for CKD drugs continues to grow at a significant pace, driven by the increasing number of CKD patients and the growing need for novel treatments to improve patients’ quality of life. The global CKD drug market stood at US$11.5 Billion in 2015. Growing at a CAGR of 3.60% between 2016 and 2024, the market’s opportunity is expected to reach US$15.8 Billion by the end of 2024.

Manufacturing

Since Mitsubishi was the single supply source of cGMP Repirinast and has since discontinued its manufacturing, Algernon has retained Zhejiang Ausun Pharmaceutical CO, LTD located in Zhejiang China, to begin manufacture of a cGMP supply. The Company believes the manufacturing will be completed in approximately five months.

Algernon’s Clinical Research Plan

The Company is in the early planning stages of its clinical research program and is considering the option of conducting its initial trial in Australia. Research conducted in Australia would be reimbursed under the Australian Scientific Research Tax Credit Program at a rate of 43.5%.

The Company has retained its Asia Pacific CRO partner Novotech to conduct a feasibility study for the Company’s Repirinast CKD clinical research plan.

The Company is also planning to conduct trials in the U.S. and will accordingly file a pre-IND application with the U.S. Food and Drug administration.

Since there is no current Repirinast finished product to use as a comparator for Algernon’s planned new cGMP supply, the Company will conduct a bridging sub-acute toxicology study when the Repirinast cGMP synthesis is completed. The sub-acute toxicology study is expected to take approximately 90 days.

Additionally, the Company is planning to conduct a small Phase 1 study in Q4, 2022, to determine the bioavailability of its newly planned Repirinast finished product.

Algernon CKD Program Lead Consultant

Dr. Chirag Parikh, MD, PhD, FACP

Dr. Parikh is the Director, Division of Nephrology and Professor of Medicine at Johns Hopkins University. He is board-certified in both Nephrology and Internal Medicine. He conducts an active patient-oriented research program investigating the translational and epidemiological aspects of acute kidney injury (AKI) and other kidney related disorders.

Dr. Parikh has authored more than 250 peer-reviewed papers, 50 book chapters and reviews, and he has given more than 50 invited lectures at scientific meetings and academic institutions around the world. He has received several awards, including the National Junior Physician Investigator Award from the American Federation of Medical Research and the Outstanding Investigator Award from the Society of Clinical Investigation.

CRO’s

In addition to Novotech, Algernon has also retained CRO Clinical Development Solutions to support all aspects of the investigational brochure, study protocol and Pre-IND and IND applications and will provide high-level oversight and management of all clinical trials.

Intellectual Property

Algernon’s patent applications for Repirinast include the treatment of CKD as well as dosing and in combination with several cholesterol-lowering or antihypertensive drugs.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.