Disseminated on Behalf of: Algernon Pharmaceuticals
- Algernon sold its Ifenprodil research program in Q2 of this year to U.S. based Seyltx, Inc. for US$2 million and a 20% common share equity position
- Sub-psychedelic DMT has been shown to promote brain healing neuroplasticity both in vitro and in vivo, and is now Algernon’s primary research focus
- Addressable global markets for stroke and traumatic brain injury (TBI) therapies are projected to grow to US$15 billion by 2027 and US$4.5 billion by 2026, respectively
From Mind-Bending to Mind-Mending
Every hour of every day, in hospitals around the world, devastated family members keep vigil in waiting rooms and at bedsides, hoping and praying that the stroke their loved one just had does not leave them with catastrophic physical and/or cognitive disabilities, or take their life.
A stroke occurs when the blood supply to a part of the brain is interrupted — either through a blockage (ischemic stroke) or an uncontrolled bleed (hemorrhagic stroke) shutting down the delivery of oxygen and nutrients that can result in paralysis, speech/language problems, thinking and memory issues, and other forms of potentially permanent functional impairment. A TBI occurs as a result of an external force to the head caused by falls, vehicular accidents, sports injuries, assaults, combat injuries, and other impacts.
For strokes, depending upon the type and severity, how fast a patient gets to the emergency room, the kind of medical centre receiving the patient, CT or MRI imaging availability and diagnosis, the therapeutic window, and candidate criteria for procedures, the vast majority of patients are unable or ineligible to receive the most effective intervention therapies available to help stop, reverse, and reduce any potential loss of function.
These therapies could include tPAs (Tissue Plasminogen Activator) to break up clots, blood thinners, a thrombectomy to physically remove a clot, or angioplasty and stent placement to open a blocked artery and restore blood flow to the brain. The intervention dynamics for TBIs are limited as well and primarily focus on trying to reduce inflammation that happens after the injury occurs.
In response to this global need for more universal and broadly deliverable, frontline treatments, Algernon Pharmaceuticals Inc. (CSE: AGN | OTCQB: AGNPF | FSE: AGW0) (AGN Pharma), through its wholly-owned subsidiary Algernon NeuroScience (AGN Neuro), is working to repurpose psychedelic DMT from a mind-bending hallucinogenic, to a mind-mending sub-psychedelic therapeutic, that could potentially be administered to greater numbers of patients to help improve post-stroke and post-TBI outcomes for millions worldwide.
Building Confidently on Ifenprodil’s Success
With its Ifenprodil research program now sold to U.S. clinical-stage biopharmaceutical company Seyltx, Inc. for US$2 million and a 20% common share equity position, AGN Pharma has been able to move its DMT research program to lead status.
AGN Pharma CEO Christopher J. Moreau remains proud of the groundwork his company did on Ifenprodil, including a Phase 2a clinical trial for idiopathic pulmonary fibrosis (IPF) and chronic cough, and is confident in passing the baton to Seyltx to fund, design, and direct the drug’s next developmental stages.
“I believe that Ifenprodil, which acts centrally in the brain, is a first-in-class potential treatment for chronic cough, and could outperform all other drugs that have been clinically investigated to date,” says Moreau.
As a result of AGN Pharma’s carried equity position in Seyltx, Moreau believes the company and its shareholders are also well positioned to participate in any future upside, given the global chronic cough market is projected to grow up to US$11.38B by 2029, which he says is essentially being served at present by little more than flavoured lozenges and sugary syrups.
Moreau also reminds investors that positive Phase 2b data for other refractory chronic cough drugs in clinical development, resulted in two significant acquisitions by big pharma.
“Merck & Co. acquired Afferent Pharmaceuticals along with the rights to their drug gefapixant for refractory chronic cough applications in a deal valued at up to US$1.25 billion, and most recently GSK plc similarly acquired Bellus Health and the rights to camlipixant, its own novel P2X3 receptor antagonist, for US $2B,” says Moreau.
Sub-Psychedelic DMT – Healing Without Hallucinations
With Seyltx now taking the lead on Ifenprodil, AGN Pharma is focusing its primary attention on accelerating its investigation of DMT for stroke and TBI recovery through its subsidiary AGN Neuro, with stroke being the company’s first-up target for clinical trials.
A naturally occurring, endogenous psychedelic compound that has been known to humankind for centuries, DMT or N,N-dimethyltryptamine has been controversially controlled by the U.S. DEA as a Schedule 1 drug for the last 53 years, thereby restricting its use and limiting its research in the U.S.
In the 1970’s, President Nixon, known to have despised recreational drug use as much as the hippie movement of the era it was associated with, moved to have DMT, along with a number of other psychedelic substances like LSD and psilocybin, prohibited, and they remain so to this day.
“In essence, Schedule 1 drugs are described in the classification as having no accepted medical use, something easily countered with solid data, which we have been building,” says Moreau.
Of note, Robert F. Kennedy Jr., President-elect Trump’s pick for his new Health and Human Services Secretary, recently announced on social media platform X that “FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics…”, so things may be about to radically change for these controlled substances in the U.S.
Despite all of the rhetoric and fear of psychedelic drugs, Moreau’s teams have focussed on investigating sub-psychedelic levels of DMT, including a preclinical study they did showing a 40% increase in cortical neuron growth. Moreau also sites independent preclinical research conducted at the University of California, Davis showing that a sub-psychedelic DMT dose in rats was sufficient to get their brains to begin rewiring.
Says Moreau, “I think it is intuitive that after a brain injury, it’s better to not be sending a traumatized patient on a psychedelic journey, so we are glad the preclinical data has shown that a sub-psychedelic dose of DMT is all that is required to promote neuroplasticity and synaptic growth.”
AGN Neuro completed a successful Phase 1 DMT study last summer using multiple doses at the Centre for Human Research in the Netherlands, meeting safety and tolerability criteria including at the highest dose, which was below the psychedelic level.
The psychedelic level of DMT was previously identified as being 0.2 mg/kg by Dr. Rick Strassman, DMT researcher and author of the book DMT: The Spirit Molecule (2001), and AGN Neuro consultant, in his ground-breaking DMT human studies in the early 1990s.
Stroke and TBI — A US$19.5 Billion Projected Market
With close to US$5million invested to date on pre-clinical and clinical DMT studies, Moreau says he is focused now on positioning AGN Neuro for a big play — a 40 patient Phase 2a DMT study, with the intention of the company completing a direct IPO on the NASDAQ on the heels of anticipated positive data, and a potential corresponding surge in valuation at that point of between US$50–$100 million.
Investors may also find appeal in the addressable global markets for stroke and TBI therapies, projected at US$15 billion by the year 2027 and US$4.5 billion by the year 2026, respectively.
This is being driven by more than 12.2 million new strokes each year globally, making stroke the second leading cause of death and the third leading cause of disability worldwide. TBI also contributes dramatically to global death and disability annually with sixty-nine million people estimated to experience TBI worldwide every year. Strokes are shockingly on the rise among younger people as well, with prevalence for those aged 18–44 growing by 14.6%.
The randomized, double-blind, placebo-controlled Phase 2a DMT study of 40 actual stroke patients is planned to begin in the second quarter of 2025. AGN Neuro is in discussions with Dr. Sandor Nardai of the National Institute of Mental Health, Neurology and Neurosurgery in Budapest, Hungary, to be the Principal Investigator.
Dr. Nardai, one of Europe’s leading stroke experts, studied DMT in 2020 in rats that had ischemic stroke induced, and showed among other findings, that rats treated with sub-psychedelic DMT recovered almost full motor function, as well as had a much smaller area of damage in the brain compared to untreated rats. This latter finding was suggestive that DMT might have protective, as well as restorative qualities.
The primary endpoint for the study will be safety, with secondary endpoints to include impacted cognitive factors such as vision, hearing, sound, aphasia, and motor function, as well as brain infarct volume.
“We have been diligently building on our work, and that of independent investigators for the last several years, showing how DMT promotes neuritogenesis and synaptic growth. We are now ready to move into larger human trials with actual ischemic stroke patients to further show DMT’s safety, and its efficacy related to stroke recovery,” says Moreau.
Following successful Phase 2a study data, Moreau plans to scale up for an expansive Phase 2b clinical trial, that he anticipates being supported by the U.S. FDA at that time, with U.S. trial sites to be included in the study plan. Plans also include filing for Breakthrough Therapy and Fast Track designations for DMT with the U.S. FDA to more quickly advance its approval.
The market has been previously advised that AGN Pharma has filed patents for DMT pamoate and nicotinate (novel salt forms of DMT) in addition to formulation, dosage and method of use claims for ischemic and hemorrhagic stroke, as well as traumatic brain injury (TBI).
To learn more about Algernon Pharmaceuticals Inc., visit their website here, or its wholly-owned subsidiary Algernon NeuroScience.