Biotech Co. Completes Step Toward Psychedelic Treatment for Brain Injuries

Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA) has announced that Algernon NeuroScience, also known as Algernon Neuro, has completed the final segment of its Phase 1 clinical study of DMT's treatment applications for stroke and traumatic brain injury (TBI).

Completion of Phase 1 Clinical Study

Algernon Pharmaceuticals Inc. has announced that its subsidiary, Algernon NeuroScience, has completed dosing the third and final cohort in its escalating dose phase 1 clinical study of an intravenous formulation of AP-188 (N, N -dimethyltryptamine or DMT). According to Algernon Neuro, the safety review committee has confirmed that patients experienced no safety or tolerability issues with the highest dose, which was able to maintain plasma DMT concentrations at the targeted levels, and which was below the established psychedelic dose of 0.2 milligrams per kilogram. Algernon Neuro is the first company to test DMT at single escalating concentrations with an IV dose for a six-hour duration.

In preclinical studies, it was found that DMT increased brain-derived neurotropic factor, which is believed to be an important part of healing the brain after an injury. DMT is believed to activate pathways involved in forming neuronal connections and has been shown to increase the number of dendritic spines, which form synapses with other neurons and are a critical site of molecular activity in the brain on cortical neurons.

According to Christopher J. Moreau, the CEO of Algernon Pharmaceuticals, "Neuroplasticity's role in healing the brain after an injury is one of the most exciting areas of research going on globally in the pursuit of a treatment for stroke and TBI, and Algernon Neuro is at the forefront of this work. Now that we have established the safety of a single sub-psychedelic dose of DMT, we are planning to accelerate our DMT phase 2 studies accordingly for both stroke and TBI."

"Consider Algernon an Immediate Buy; the company is added to my roster of speculative-rated companies," said Chris Temple of The National Investor.

The single escalating dose phase 1 trial was conducted at the Center for Human Drug Research in Leiden, Netherlands.

The study was intended to find the safety, tolerability, and pharmacokinetics of subpsychedelic doses of DMT when administered as an intravenous bolus followed by a prolonged infusion of six hours, which was selected based on clinical studies. Several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, were recorded. Algernon Neuro anticipates publishing the data from the study in an upcoming issue of a peer-reviewed scientific publication.

Based on the success of this clinical trial, the second part of the study will be scheduled to begin at a later time and will include dosing subjects for six hours with repeated administrations over a two-week period.

Catalyst: Greater Clinical Acceptance

Psychedelics have seen greater acceptance as of late. Incannex Healthcare announced that the experts Dr. Bill Richards, Professor Matthew Johnson, and Dr. Andrea Jungaberle will join the board of Clarion Clinics. All three persons have expert experience in the field of psychedelics and have been brought on to support the clinic's mission statement as Australia becomes the first country to legalize the use of psychedelic drugs to treat mental illness.

According to Dr. Paul Liknaitzky, the chief science officer of Clarion Clinics Group, "each brings deep experience and hard-won wisdom that will help guide our efforts within the Clarion venture towards supporting our clients to live their best lives." In both academics and a treatment environment, psychedelics are taking steps toward acceptance. 

Chris Temple of The National Investor rated Algernon as an Immediate Buy for investors, saying, "Consider Algernon an Immediate Buy; the company is added to my roster of speculative-rated companies."

Ownership and Share Structure

Management and insiders own 3.41% of the company. 

Institutions own 9.55% of the company. AlphaNorth Asset Management owns 8.73% with 1.27 million shares, and Palos Management owns 0.82% with 0.12 million shares. The company reports no strategic investors, and the rest is in retail.

Algernon reports that it has CA$0.5 million in the bank as of March 1, 2023. The company has a monthly burn rate of CA$80k in net clinical trial and research costs.

Algernon has a market cap of CA$4.64 million. There are 19.33 million shares outstanding, and there are 18.94 million in public float. It trades in the 52-week range between CA$0.19 and CA$1.46.

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Important Disclosures:

1. Algernon Pharmaceuticals Inc. are billboard sponsor(s) of Streetwise Reports and has paid SWR a sponsorship fee between US$3,000 and US$5,000. In addition, Algernon Pharmaceuticals Inc. is an affiliate of has a consulting relationship with Streetwise Reports and has paid a 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. Amanda Duvall wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. 
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