Welcome to the News You Might Have Missed, a weekly roundup of news items 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.
U.S. FDA Approves Nova Mentis Orphan Drug Application
The company announces that the U.S. FDA has approved the Company’s proprietary psilocybin drug Orphan Drug Application to treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).
Braxia Scientific Graduates First Cohort of Medical Professionals from Psilocybin-Assisted Therapy Training Program; Ready to Start Health Canada Approved Psilocybin Clinical Trial
The Company announced the completion of the training program for psilocybin-assisted clinical therapy by its first multi-disciplinary cohort of 20 qualified therapists from diverse psychiatry and psychotherapy backgrounds.
Tryp Therapeutics Submits IND Application for Phase 2a Clinical Trial in Fibromyalgia
The Company announced today that it has submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) to evaluate its clinical candidate, TRP-8802, in a Phase 2a clinical trial that investigates safety and preliminary effectiveness of psilocybin-assisted therapy among patients with fibromyalgia in collaboration with the University of Michigan.
Filament Health Announces FDA Authorization of Clinical Trial with First-Ever Direct Psilocin Administration and First-Ever Psychedelic Botanical Drug Candidates
Filament Health announces FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. In addition, this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament’s three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).
Red Light Holland Appoints New Chief Financial Officer
Mr. Ascott whose past includes being the CFO (2011-2018) for Rocky Mountain Dealerships Inc., an agricultural equipment company with $1B in revenue, joins Red Light Holland after most recently being a Chief Financial Officer with an early stage private cannabis producer. Mr. Ascott, a CPA with over 30 years’ experience, began his career in public practice with Ernst & Young where he progressed to Senior Manager serving a variety of clients both domestically and abroad.
MINDCURE Signs LOI with Awakn Life Sciences to Distribute Ketamine Protocol for Alcohol Use Disorder
The Company will enter into an agreement with Awakn to be a distributor of its ketamine-assisted psychotherapy for Alcohol Use Disorder (AUD) protocol in the US and Canada. Awakn’s protocol will be distributed through iSTRYM, MINDCURE’s digital therapeutics platform.
PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics
The Company has research collaborations with the Terasaki Institute to evaluate MicoDose-MN™; a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin, MDMA, LSD and DMT, and with The Queen’s University of Belfast (“QUB”) to evaluate MacroDose-MN™; a patented hydrogel-forming microneedle patch, to deliver ketamine and PharmaTher’s proprietary ketamine combination formulation, ketamine and betaine (“KETABET™”) for mental health, neurological and pain disorders.
