UK Regulator Fast-Tracks DMT Therapy for Major Depressive Disorder
This week in psychedelic business news, Small Pharma‘s work on DMT therapy for major depressive disorder has been fast-tracked by the UK’s medicines regulator. The company’s lead product candidate SPL026 has been granted Innovation Passport Designation by the Medicines and Healthcare products Regulatory Agency (MHRA). Like the Food and Drug Administration’s (FDA) fast-track process in the United States, this designation provides Small Pharma access to specialist advice throughout drug development, potentially accelerating drug approval.
Compass Pathways Pioneers Simultaneous Administration of Psilocybin in Small Groups
A new study of Compass Pathways‘ COMP360 psilocybin therapy, conducted by the Maryland Oncology Hematology at the Aquilino Cancer Center, has shown the simultaneous administration of psilocybin to two to four patients with therapist support is feasible. Researchers tested the value of group support for patients in addition to the potential for scalability and providing psilocybin therapy in real-world settings. However, researchers noted while these results were promising and worthy of further research, they were premature.
Nova Mentis Life Science and Mycrodose Therapeutics Partner on Development of Drug Delivery System
Biotechnology company Nova Mentis Life Science and pharmaceutical company Mycrodose Therapeutics have entered into a letter of intent to develop products to treat neuroinflammatory disorders such as fragile X syndrome and autism spectrum disorder. “With the high safety profile of Mycrodose’s technologies and Nova’s FDA and European Union fragile x syndrome orphan drug indication for its proprietary psilocybin, this partnership opens microdosing psilocybin-based drugs to a broader patient base, including pediatric applications,” said Mycrodose Therapeutics CEO Chad Conner.
Cybin Completes 74 Pre-Clinical Studies to Progress Propriety Psychedelic Molecules
Biotechnology company Cybin revealed this week that it had completed 74 in-vitro and in-vivo studies on its portfolio of more than 50 psychedelic compounds. The results showed Cybin’s compounds had several potential advantages over classical psychedelic molecules, including the faster onset of action, shorter duration of action, and less inter-subject variability — all properties that could lead to improved patient outcomes.
Field Trip Health Expands Network of Psychedelic-Assisted Therapy Centers
On the access side of psychedelics, Field Trip Health announced that it had opened new clinics in Seattle — its sixth in the United States — and Fredericton, New Brunswick, in Canada. Another clinic is slated to open soon in Vancouver, Canada. The company’s Chief Clinical Officer Dr. Ryan Yermus said: “As we continue to grow into new markets, the potential to positively change people’s lives is endless.”
Algernon Pharmaceuticals Applies for Listing on Nasdaq Capital Market
Finally, in psychedelic business stock news, Canadian drug re-purposing company Algernon Pharmaceuticals has filed to list its common shares on the Nasdaq Capital Market. The company hopes the move to a national US stock exchange will attract new investors. This comes after Algernon Pharmaceuticals recently received a $2 million (CAD) cash payment from a refundable tax credit program for its clinical research in Australia, bringing its working capital balance to $3.5 million (CAD).
