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.
PharmaTher Receives FDA Approval for Ketamine Phase 2 Trial
PharmaTher has taken another important step in its clinical trial process. The FDA has accepted its investigational new drug (“IND”) application to proceed with a Phase 2 clinical trial using ketamine in the treatment of Amyotrophic Lateral Sclerosis (“ALS”), also known as Lou Gehrig’s disease.
MYND Life Sciences Announces Collaborative Research Agreement with the University of British Columbia
“We are very excited to announce our second Collaborative Research Agreement focussing on diseases of the brain,” stated Dr. Lyle Oberg, MYND’s Chief Executive Officer. “We have a unique opportunity to improve the wellness and quality of life of millions of people and families torn apart by the tragedy of dementia and other debilitating diseases of the Central Nervous System…”
Mydecine to Launch Special Access Support and Supply Program in Canada Expanding Access to Psychedelic-Assisted Psychotherapy For Patients
With the addition of psilocybin and MDMA to Health Canada’s Special Access Program, Mydecine looks to offer a package of cGMP products and support services promoting responsible administration to patients and creating near-term revenue potential
Numinus Submits Clinical Trial Application for Phase 1 Trial on Proprietary Psilocybin Product
“This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies,” says Sharan Sidhu, Science Officer and General Manager, Numinus Bioscience. “The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”
PharmAla Biotech Announces Listing on the Canadian Securities Exchange
Nick Kadysh, PharmAla’s Chief Executive Officer, said, “I am very excited for this milestone. With Health Canada’s recent changes to the Special Access Program, there has never been a better time to go public as a psychedelics company. Special thanks to our shareholders for their support and confidence in PharmAla’s dual mission: to research and develop novel patented molecules and formulations in the MDXX class, and the manufacturing of MDMA to support clinical research.”
atai Life Sciences announces FDA Investigational New Drug (IND) Clearance for PCN-101 R-ketamine Program
The company announced the U.S. Food and Drug Administration (FDA) has given Investigational New Drug (IND) clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). atai plans to initiate the study early this year through its platform company Perception Neuroscience.
Wesana Health Provides Strategic and Operational Updates
- Wesana granted pre-IND meeting with FDA, currently set for March 11, 2022
- Wesana Clinics exhibited a record quarter of billings, new patient visits, telemedicine utilization, overall patient appointments, and ketamine administrations
- New flagship clinic set to open in late Q1 2022 showcasing the service evolution of Wesana Clinics
- Strategic restructuring program to realize $1.1M in general corporate overhead reduction and improve operational efficiencies
