Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.
Small Pharma Reports Positive Results from Phase IIa DMT Trial
Big news as Small Pharma has announced positive topline results for its Phase 2a trial using DMT for depression.
- Primary endpoint met with a statistically significant -7.4 point difference between SPL026 (21.5mg) and placebo at two-weeks post-dose as measured by MADRS change from baseline (p=0.02)
- Antidepressant effect of SPL026, with supportive therapy, demonstrated a rapid onset at one-week post-dose with a statistically significant difference in MADRS of -10.8 versus placebo (p=0.002)
- Durable antidepressant effect with a 57% remission* rate at 12-weeks following a single SPL026 dose with supportive therapy
Irwin Naturals Signs Letter of Intent to Acquire Braxia Scientific
Under the terms of the LOI, Irwin is prepared to offer a purchase price per Braxia Share based upon a valuation of the outstanding Braxia Shares of US$30,000,000.
- Establishes large footprint of 17 specialized mental health clinics across North America, and 5 more under definitive agreement with Irwin Naturals, enhanced by a telehealth platform expected to extend access to critical treatments for millions of people across multiple states in the US.
- Combined network of clinics creates a leading international mental health research platform for in-human clinical development of novel therapeutics.
Awakn Life Sciences Initiates Investigative Study of Novel Formulation of (S)-ketamine to Assess Dissociative Effect
The trial’s participants will consist of harmful drinkers, they will be administered with a dose of (S)-ketamine delivered via a proprietary oral thin film formulation. The study will evaluate the dissociative effect garnered from the formulation and look at alcohol cravings from participants.
If the results of this study are positive, it will potentially lead to a global licensing agreement for phase I data of the patent pending oral thin film (S)-ketamine formulation. This could result in Awakn advancing to a larger phase II b study and having global exclusivity rights to use the thin film formulation in the treatment of all addictions.
Health Canada Approves Diamond Therapeutics’ Phase 2 Trial of Low-Dose Psilocybin
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Diamond’s Phase 2 trial has been approved by Health Canada, a four-week, Phase 2 randomized, double-blind study in adult patients with Generalized Anxiety Disorder (with the potential for an additional four-week open-label extension. Patients will receive repeat low doses of psilocybin administered on a take-home basis.
This Phase 2 trial follows Diamond’s Phase 1 trial of fifty-six subjects that established a safe, tolerable dose range for the use of low, non-psychedelic doses of psilocybin.
PharmaTher Holdings Submits for FDA Orphan Drug Designation for Ketamine to Treat Rett Syndrome
PharmaTher has applied with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat Rett Syndrome, a rare genetic neurological disorder. Ketamine has been subject to a Phase 2 clinical trial (NCT03633058) for Rett syndrome. Unpublished results from this study will be evaluated to support a potential Phase 3 clinical study and FDA agreement on a regulatory plan for approval which the Company may pursue.