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Psychedelics biotech Awakn Life Sciences Corp. (OTCQB:AWKNF) has begun an investigative study on the dissociative effect of a proprietary and patent-pending formulation of (S)-ketamine, as well as an optimized administration route to support the new drug’s commercialization.
The new study’s cohort will include harmful drinkers, who will be administered a dose of (S)-ketamine through a novel oral thin film formulation.
After dosing, researchers will evaluate the dissociative effect through participants’ alcohol cravings, as well as mechanistic factors including electroencephalographic (EEG) markers of increased neuroplasticity.
Should results be positive, the partners would potentially sign a global licensing agreement for the Phase 1 study data of the patent-pending oral thin film (S)-ketamine formulation. This, in turn, would take Awakn to move forward to a larger Phase 2b study, as well as to hold global exclusivity rights on the thin film formulation in the treatment of all addictions.
"This study is really exciting for the future of ketamine-assisted therapy (KAP) in the treatment of alcohol problems. If we find a signal that this new formulation may work in Alcohol Use Disorder (AUD), then this could open up KAP to a much wider range of clinicians, practitioners and patients,” said the study’s PI, Prof. Celia Morgan.
She further commented the research could eventually also help extend this therapy to other indications: “Our previous evidence has shown that ketamine-assisted therapy works in alcohol use disorder, but this is somewhat limited due to the need to give the ketamine intravenously. This may then herald the advent of a much more widely available new treatment for people struggling with alcohol problems who are not currently being served by existing treatments."
Toronto-based psychedelic therapies development company Diamond Therapeutics Inc. received Health Canada’s approval for a Phase 2 clinical trial evaluating safety, tolerability and efficacy of repeated low doses of psilocybin for the treatment of Generalized Anxiety Disorder (GAD).
The condition makes people experience considerable impairment and disability, similar to often concurrent major depression, which is associated with decreased work productivity and increased use of health care services.
Nonetheless, few stage-advanced clinical studies are exploring new treatment options to date.
This randomized, double-blind study will last four weeks with the potential for an additional four-week open-label extension.
Participants are adults with diagnosed GAD who will receive several low doses of psilocybin for them to self-administer on a take-home basis, which is quite a novelty within the universe of psychedelic clinical trials.
Diamond’s CMO Dr. Michael B. McDonnell explained that following the results of the Phase 1 trial’s proven safe, tolerable, the non-hallucinogenic range for low psilocybin doses on an outpatient basis, the current Phase 2 trial will explore subjective and cognitive effects plus effects on quality of life in adults with GAD.
"We are grateful for Health Canada's approval of Diamond's latest clinical trial application, which brings us closer to our goal of developing psilocybin-based medicines that are safe and effective for patients, that are better than the current first-line, and that may be prescribed on an outpatient basis, removing the barrier of lengthy time spent in a clinic," added CEO Judy Blumstock.
Photo: Benzinga edit with photo by Pexels.
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