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DMT Study Set To Explore Breakthrough Potential in Stroke Recovery

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Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW0:XFRA) subsidiary Algernon NeuroScience has appointed Dr. Sndor Nardai as Principal Investigator for its upcoming Phase 2a DMT stroke study. Find out how this trial could reshape stroke recovery research.

Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW0:XFRA) announced that its subsidiary, Algernon NeuroScience, has appointed Dr. Sándor Nardai as the Principal Investigator for its upcoming Phase 2a clinical study evaluating N,N-Dimethyltryptamine (DMT) as a potential treatment for stroke patients. The study, which is set to begin in the third quarter of 2025, will be a randomized, double-blind, placebo-controlled trial involving 40 stroke patients in Europe.

Dr. Nardai, a leading cerebrovascular disease specialist, is currently the Head of the Department of Neurointervention at Semmelweis University in Budapest, Hungary. He previously led a preclinical study published in Experimental Neurology in May 2020, which demonstrated that rats treated with sub-hallucinogenic doses of DMT showed near-complete motor function recovery and smaller infarct volumes compared to untreated control groups. This research provided the basis for Algernon's clinical investigation into DMT as a potential neuroprotective agent for stroke recovery.

"The primary endpoint of the planned Phase 2a study will be safety," said Dr. Nardai in the news release. "However, stroke clinicians worldwide will also be watching for positive signals regarding lesion volume, biomarkers, motor function, cognitive function, depression, and mortality."

DMT, a hallucinogenic compound found naturally in various plants and animals, is believed to promote neuroplasticity and brain-derived neurotrophic factor (BDNF) release. These properties make it a candidate for stroke recovery therapies. Algernon has filed multiple patents related to its proprietary DMT formulations, including DMT pamoate and nicotinate, and is developing novel dosing methods to optimize its therapeutic effects.

Biotechnology and Biopharmaceuticals: Global Momentum

On January 6, Precedence Research reported that the global biopharmaceuticals market was valued at approximately US$537.54 billion, with projections indicating growth to around US$1.8 trillion by 2034. This growth was driven by rising demand for innovative therapies, increased research and development expenditures, and the global prevalence of chronic diseases. The report highlighted that North America accounted for 46% of the global market share, largely due to significant healthcare spending, a strong intellectual property framework, and the rapid approval of biologics and biosimilars.

According to BioSpace, on January 8, mergers and acquisitions in the biotech sector more than doubled in the first quarter compared to the same period in the previous year. This surge followed the Federal Reserve's interest rate cuts throughout the prior year, which made investments in biotech more attractive due to lower borrowing costs. BioSpace also noted that biotech follow-on issuance activity rose by 64%, reflecting growing investor confidence after a period of market uncertainty.

Forbes, on January 23, emphasized the increasing role of AI in life sciences, noting that the Stargate Initiative would enhance the sector's capabilities in analyzing large datasets, improving patient recruitment, and accelerating drug development. The integration of AI was viewed as a transformative force, with applications spanning from early-stage research to commercialization strategies.

On February 6, Leyton.com highlighted the complex state and local tax landscape affecting biotech firms, particularly concerning income tax apportionment, sales tax exemptions, and R&D tax credits. The report noted that biotech companies operating across multiple jurisdictions faced increased compliance burdens but could benefit from strategic tax planning to optimize financial performance.

Algernon NeuroScience Advances Drug Repurposing Strategy with Key Phase 2a Milestone

Algernon NeuroScience's upcoming Phase 2a study marks a critical milestone in its broader research strategy, which focuses on repurposing existing compounds for high-impact medical needs. As cited in the investor presentation on the Algernon website, the company's approach to drug development is designed to mitigate the risks associated with early-stage research by using compounds with known safety profiles. This method allows for potentially faster regulatory approvals and lower overall development costs.

Beyond its DMT stroke program, Algernon has another research program that includes a treatment for chronic kidney disease. The Company recently sold its ifenprodil chronic cough program to a private US-based drug development company called Seyltx for $2M USD and a 20% equity position.

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With a track record of obtaining patent protections, including methods of use, new formulations, and dosing, Algernon is positioned to leverage its intellectual property portfolio in upcoming clinical stages. If the Phase 2a trial yields promising safety and efficacy signals, it could pave the way for further studies and potential regulatory discussions regarding DMT's role in stroke treatment.

Ownership and Share Structure

According to the company, management and insiders own about 11% of the company, and about 21% is owned by institutions. The rest is with retail.

Top shareholders include Alpha North Asset Management with 20.52%, Chief Executive Officer Christopher Moreau with 5.05%, Chairman of the Board Harry Bloomfield with 1.97%, and Chief Financial Officer James Kinley with 1.4%, and Director Rajpaul Attariwala with 1.2%.


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Important Disclosures:

  1. Algernon Pharmacueticals Inc. has a consulting relationship with Street Smart an affiliate of Streetwise Reports. Street Smart Clients pay a monthly consulting fee between US$8,000 and US$20,000.
  2. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Algernon Pharmaceuticals Inc.
  3. James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. 
  4.  This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
  5. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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