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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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Microdosing for stroke recovery

Psychedelic Pharmaceutical Startup Ninnion Announces Patent Filings and Development of NIN-S119 for Ischemic Stroke

Ninnion Therapeutics, a private Texas-based company, hopes microdosing will help patients recover from strokes.

Ischemic strokes block blood flow to the brain, causing brain cells to die. 

Microdosing in combination with occupational therapy may be able to strengthen the remaining brain cells to restore lost functions.

The company recently filed a patent application for the treatment. Since there are no approved drugs for stroke recovery, the formulation may qualify for a Breakthrough Therapy designation, which would speed up the development timeline. 

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Core One Labs’ Akome Receives Positive Results from Bioassay Studies Will Look to Advance its Psychedelic Based Formulations

Core One Labs’ Akome Receives Positive Results from Bioassay Studies Will Look to Advance its Psychedelic Based Formulations

Vancouver, British Columbia, Canada – April 2, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) through a research arrangement with Neuro-Zone Srl, (“Neuro-Zone”) based in Bresso, Italy, has achieved positive results from its in vitro biological assay (“bioassay”) development studies (“bioassay studies”); furthering the Company’s patent pending psychedelic bioactive compounds that could lead to groundbreaking drug formulations for  Alzheimer’s Disease (AD), Parkinson’s Disease (PD), Major Depressive Disorder (Depression) and Stroke, (collectively “targeted diseases” or “neurological indications”).

Bioassay studies are one of the most important tools in new drug discovery and development as they identify whether a compound or, in Akome’s research scenarios, bioactive compounds, have the desired effect on targeted disease pathways.

Neuro-Zone’s bioassay studies have, to date, focused on confirming the relationship between the plant bioactives covered in Akome’s United States Patent and Trademark Office (USPTO) patent submissions, (namely AKO001, AKO002, AKO003 and AKO004 (see Company press releases dated June 19, 2021, May 6, 2021, July 21, 2021, and July 26, 2021, respectively), and the underlying neuropathological mechanisms related to conditions such as AD, PD, Depression and Stroke.

Neuro-Zone’s bioassay studies have allowed researchers to assess the effect of Akome’s plant bioactives on various biological targets associated with the neurological indications in question. Positive results emerging from the bioassay studies indicate that Akome’s plant bioactives possess the desired biological effects against Alzheimer’s Disease neuropathological mechanisms, as well as against other neuroinflammatory processes.

Using these positive results Akome and Neuro-Zone are actively mapping out the next stages in the Company’s drug development process.

“The positive results from these studies have demonstrated that Akome is making significant steps towards developing groundbreaking drug formulations that can be used to treat neurological diseases. This is great news for the tens of millions of people who are affected by Alzheimer’s, Parkinson’s, Depression and Stroke, across the globe” stated Joel Shacker, the Company’s CEO.

About Neuro-Zone

Neuro-Zone is a functional service company supporting drug discovery and research projects in the fields of inflammation and age-related pathologies, including underlying mechanisms of common brain diseases. With their added value deep scientific knowledge and cutting-edge technological platforms, Neuro-Zone studies the cell-cell interactions and biological activity of the Company’s new candidate drugs and provide understanding on the role of the microenvironment in the complex disease scenarios.

About Core One Labs Inc. 

Core One Labs is a life sciences biotechnology research and development company focused on bringing psychedelic medicines to market through the development and production of psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery systems technology.

The Company has a multi-faceted business approach and incorporates several complementary lines of businesses and units in establishing itself as an industry leader in the rapidly growing and emerging psychedelics market space.

Core One, through its wholly owned subsidiary Vocan Biotechnologies Inc., has developed and filed for patent protection of a proprietary psilocybin production system using engineered bacteria. It is also the holder of 4 provisional patents for the development of psychedelic-based pharmaceutical formulations targeting neurological and mental health disorders, under its 100% owned subsidiary Akome Biotech Ltd., and 3 provisional patents under its other 100% owned subsidiary, Awakened Biosciences Inc., for additional synthetic technologies for psilocybin and psilocin production methods.

In addition to the development of psychedelics and psychedelic compounds, Core One holds an interest in four medical clinics which maintain a combined database of more than 275,000 patients. Through its clinics the Company intends to integrate a roll out of its intellectual property related to psychedelic technologies and participate in the advancement of psychedelic-based treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations

Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations

Vancouver, British Columbia, Canada – March 4, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”), has entered into an agreement with the Universidad Complutense de Madrid (“Universidad Complutense”), officially commencing neurogenesis stimulation and modelling studies research, to advance the development of the Company’s patent pending psychedelic bioactive compounds that target Alzheimer’s Disease, Parkinson’s Disease, Major Depressive Disorder and Ischemic Stroke.

Neurogenesis is the ability of the brain to grow new neurons. Until recently, neuroscientists believed that the central nervous system, including the brain, was incapable of neurogenesis and unable to regenerate. However, research conducted over the last two decades confirms, not only that adult neurogenesis is a normal process that occurs in the healthy brain, but also that it can be enhanced by psychedelics among other potent stimulants. Neurogenesis is considered important in neuroplasticity, the ability of the brain to form new connections and pathways and change how its circuits are wired. Through Akome’s initial data mapping of how psychedelic substances and selected bioactive substances cooperate, there is potential for significant stimulus in adult neurogenesis in the brains of individuals that are afflicted with certain neurological disorders, and Akome’s research with Universidad Complutense seeks to prove that its chosen bioactive-compounds can enhance such processes.

The research, which is currently underway, is being led by Dr. Jose A. Morales-Garcia, PhD, of the Universidad Complutense de Madrid, a leading institution with extensive experience in psychedelics research, and neurodegenerative processes responsible for conditions such as Alzheimer’s disease, Major Depressive disorder, Parkinson’s disease and ischemic stroke. The scope of research is designed to advance the Company’s hypothesis that the selected candidate bioactive compounds included in its patent submissions, are viable candidates and will react positively upon targets in the Central Nervous System, and have the potential to stimulate neurogenesis in the brain of individuals afflicted with neurological disorders, and subsequently result in groundbreaking clinical implications for the indications of Ischemic stroke, Alzheimer’s disease, Major Depressive disorder and Parkinson’s disease.

Dr. Morales is an Assistant Professor and Honorary fellow in the Cellular Biology Department at the Complutense University of Madrid, Medical School, a scientist at the Center for Networked Biomedical Research on Neurodegenerative Diseases, as well as a professor in the Master of Pharmacological Research at the Autonoma University of Madrid. Dr. Morales has over 40 scientific publications in peer-reviewed journals.

Dr. Morales’ has vast research background in the identification and analysis of new cellular targets implicated in neurogenesis and neurodegeneration as well as focused work in the study in vitro and in vivo of the mechanism underlying neurodegenerative disease, mainly Alzheimer´s and Parkinsonism in order to develop new neuroprotective, anti-inflammatory and neurogenic compounds for the treatment of these disorders.

“I believe that the treatment of individuals with neurological disorders through the use of psychedelic based pharmaceuticals, will become a major focus of mental healthcare in the near future. The groundbreaking work that Universidad Complutense is doing for Akome, will contribute significantly to the advancement of our drug formulations as we work to commercialize our patents. By developing unique psychedelic based pharmaceutical formulations that can be used for the treatment of Alzheimer’s, Parkinson’s, Depression and Ischemic Stroke, the Company is positioning itself to serve a larger and more diverse patient base,” stated Joel Shacker, the Company’s CEO.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Core One Labs’ Akome Biotech Signs Research Agreement with University of Barcelona, Faculty of Pharmacy and Food Sciences

Core One Labs’ Akome Biotech Signs Research Agreement with University of Barcelona, Faculty of Pharmacy and Food Sciences

Vancouver, British Columbia, Canada – January 26, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has signed a consulting agreement with the Universitat de Barcelona (the “University of Barcelona” or the “University”), Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry, of Barcelona, Spain.

By virtue of this agreement, Professor Maria Carmen Escolano, a full professor at the University’s Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, and her team will provide technical guidance for the in vitro development of Akome’s psychedelic based bioactive compounds targeting Major Depressive Order, Stroke, Parkinson’s Disease and Alzheimer’s Disease.

The University of Barcelona, Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry, has been selected by Akome as the successful candidate organization to provide technical guidance for the necessary in vitro studies of its proposed pharmaceutical psychedelic drug formulations.

Conducting in vitro studies is essential in the development of any new pharmaceutical drug. In vitro studies determine whether a pharmaceutical candidate produces the desired changes on cell cultures as an early indicator of efficacy. These studies are usually completed quickly and are designed based on information already presented in the provisional patents that have been filed by Akome.

Professor Escolano received her PhD from the University of Barcelona in 1993. Upon completion, she undertook research posts at the University College of London and Kingston University (UK) working in the synthesis of complex molecules with biological interest. Professor Escolano currently serves as a full professor at the Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, a post she has occupied for the last 14 years.

Professor Escolano leads the medicinal research group at the Universitat de Barcelona. The focus of this research group is the pharmacology of neurodegenerative diseases. Professor Escolano and her group have conducted in vitro development of multiple candidate substances for the treatment of neurological conditions. Professor Escolano is a renowned authority in the field, with over 95 publications in textbooks and peer-reviewed scientific journals. Akome is looking forward to the advancement of its pipeline of bioactive compounds specifically those targeting the neurodegenerative diseases, Parkinson’s and Alzheimer’s.

“We are excited to announce our contract with the University of Barcelona, Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry,” stated Joel Shacker CEO of the Company.  “Professor Escolano and her team have an enormous amount of experience, and knowledge of the targeted diseases, and the research acumen that will allow Core One to efficiently move forward with the more in-depth in vitro and in vivo studies that are necessary in effectively mapping out development of pre-clinical trials.”

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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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

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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.

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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

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Treating meth addiction and brain damage

Revive Therapeutics Provides Update on Psychedelics Clinical Product Pipeline

Revive Therapeutics (RVV) is partnering with the University of Wisconsin-Madison to conduct two exciting new psilocybin studies.

One study will research the effect of psilocybin on traumatic brain injury (TBI) and strokes, expanding on preclinical findings that psilocybin improved cognitive function in mice with TBI.

Revive will also conduct a Phase 1/2 clinical study to determine psilocybin’s impact on adults with methamphetamine use disorder. Both studies will begin patient enrollment by the end of the year.

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