Posted on

Algernon Pharmaceuticals Discloses Novel Salt Patent Strategy as Part of its Psychedelic Drug DMT Intellectual Property

Algernon Pharmaceuticals Discloses Novel Salt Patent Strategy as Part of its Psychedelic Drug DMT Intellectual Property

VANCOUVER, British Columbia, Jan. 24, 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 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 novel salt forms of DMT. 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.

Many drug compounds’ core structures can often be paired with a salt. Different salts can improve the core drug in several ways, including improved efficacy, safety/tolerability, and stability.

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

The Company recently announced on January 18, 2022, that it has filed a combined Clinical Trials of Investigational Medicinal Products and Ethics Approval application, with the United Kingdom Medicines and Healthcare Products Regulatory Agency for its planned Phase 1 DMT clinical human stroke study.

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.

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

Microdosing DMT

Algernon Pharmaceuticals Files for Clinical Trial and Ethics Approval for Phase 1 DMT Human Stroke Study

Algernon Pharmaceuticals (AGN) found that microdoses of DMT can increase the growth of neurons in the brain by up to 40%. An upcoming study will see if this can benefit stroke patients.

Phase I of the study, which is awaiting approval in the UK, will determine the maximum amount of DMT that can be taken without producing a psychedelic effect. Phase II will test repeated doses on acute and recovering stroke patients.

Algernon Logo 1.png

PDF of article

Posted on

Algernon Pharmaceuticals Files for Clinical Trial and Ethics Approval for Phase 1 DMT Human Stroke Study

Algernon Pharmaceuticals Files for Clinical Trial and Ethics Approval for Phase 1 DMT Human Stroke Study

VANCOUVER, British Columbia, Jan. 19, 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 it has filed a combined Clinical Trials of Investigational Medicinal Products and Ethics Approval application, with the United Kingdom Medicines and Healthcare Products Regulatory Agency (“UK MHRA”). This was accomplished via the combined review service, which provides for a single application route for 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 announced on November 19, 2021, that it had received positive feedback at a scientific advice meeting from the UK MHRA for its planned Phase 1 DMT Stroke study. 

The primary focus of the 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.

“We look forward to getting our DMT clinical stroke program started with our Phase 1 study at Hammersmith Medicines Research in the UK,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “This study will provide important information on dosage and duration of our new DMT IV formula to help us better plan for our Phase 2 study where we plan to test the drug with both acute and recovering stroke patients.”

Phase 1 DMT Stroke Study Summary

The purpose of the 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 aimed at identifying the maximum sub-psychedelic dose, while the second part will test the effects of repeated administrations of this dose. There will be up to 96 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 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.

Posted on

Algernon Pharmaceuticals Announces Positive Feedback from U.S. FDA for Phase 1 Ifenprodil Small Cell Lung Cancer Study

Algernon Pharmaceuticals Announces Positive Feedback from U.S. FDA for Phase 1 Ifenprodil Small Cell Lung Cancer Study

VANCOUVER, British Columbia, Nov. 24, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) a clinical stage pharmaceutical development company, is pleased to announce that it has received positive feedback from the U.S. Food and Drug Administration (U.S. FDA) at its pre-IND (Investigational New Drug) meeting for its investigation of NP-120 (Ifenprodil) for the treatment of small cell lung cancer (SCLC). Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B).

As a result of the feedback, the Company is not planning to conduct any additional pre-clinical research and will immediately move to file an IND application to begin its Phase 1 SCLC study as soon as possible. Based on the feedback from the meeting, the Company plans to use its current Ifenprodil finished product inventory for the study. The U.S. FDA meeting also produced very helpful guidance on the protocol design and endpoints for the planned SCLC study.

The Company is planning to conduct its Phase 1 study in patients with recurrent SCLC and, as a result, preliminary efficacy signals may be observed in the data.

The Company also plans to apply for orphan drug designation for Ifenprodil to treat patients with SCLC. The U.S. Orphan Drug Act grants special status to a drug for the treatment, diagnosis or prevention of a rare disease or condition.

The Company’s decision to investigate Ifenprodil and move it into human trials for SCLC is based on a preclinical study, authored by Dr. William North, and published in January 2019, entitled, “Small-Cell Lung Cancer Growth Inhibition: Synergism Between NMDA Receptor Blockade and Chemotherapy”. In the study, Ifenprodil, in combination with chemotherapeutic agent Topotecan, produced clear additive effects that significantly blocked tumor growth.

In August 2021, Algernon announced that it had signed an exclusive licensing agreement with Dartmouth College to acquire the rights to a method of use patent for treating neuroendocrine cancers, which express functional NMDA receptors. The Company also announced it appointed Dr. William North, professor emeritus at Dartmouth College and cancer research pioneer, as lead consultant.

In addition, based on the positive feedback from this Pre-IND meeting, the Company is also planning to file a Pre-IND meeting request for Ifenprodil and the investigation of pancreatic cancer in a Phase 1 study.

“We are very pleased with the response we received from the U.S. FDA,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “Being able to move directly into a SCLC Phase 1 study will save the Company considerable cost and time and will allow us to more quickly begin investigating Ifenprodil as a potential non-toxic cancer treatment option for patients who suffer from this disease.”

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 Announces Positive Feedback on its Planned Phase 1/2a DMT Human Stroke Study

Algernon Announces Positive Feedback on its Planned Phase 1/2a DMT Human Stroke Study

VANCOUVER, British Columbia, Nov. 19, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) a clinical stage pharmaceutical development company, is pleased to announce that it has received positive feedback at a scientific advice meeting from the United Kingdom Medicines and Healthcare Products Regulatory Agency (“UK MHRA”). The scientific advice meeting was related to the Company’s planned Phase 1/2a stroke study with AP-188 (“N,N-dimethyltryptamine” or “DMT”), a known psychedelic compound that is part of the tryptamine family.

As a result of the meeting, the Company plans to file a Clinical Trial Authorisation (CTA) application for the study as soon as possible. In addition, and based on the feedback received, the Company is also considering focussing on DMT as a possible treatment for acute stroke for the Phase 2a part of the study, in addition to investigating DMT as an adjunctive treatment for stroke rehabilitation therapy.

The Company is planning to conduct the Phase 1 part of the study at Hammersmith Medicines Research in London, UK and is now targeting to begin the study in January 2022.

“We were very encouraged by today’s meeting with the UK MHRA,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “The feedback we received was very helpful and we look forward to working with the agency as we move forward with the important work of investigating DMT as a possible therapy for stroke patients globally.”

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.

Algernon has filed provisional patents for new 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 Constraint Induced Movement Therapy.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, and 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