Psychedelic Business Spotlight: December 3

MAPS and Vine Ventures Pioneer Novel Regenerative Funding Structure with $70 Million Investment in MDMA Research

This week in psychedelic business news, the Multidisciplinary Association for Psychedelic Studies (MAPS) and Vine Ventures have partnered to create a social impact Special Purpose Vehicle, called the Regenerative Financing Vine, that will infuse $70 million into patient access infrastructure and research for MDMA-assisted therapy for PTSD. This model fully maintains both MAPS’ nonprofit mission and governance and MAPS Public Benefit Corporation’s public benefit drug development and post-approval activities, while offering Vine 6.1% of North America MDMA revenue for 8 years following initial drug sales. “We are pioneering a unique financing mechanism that allows MAPS to accelerate access within the market once the treatment is approved, yet ensuring our assets remain 100% non-profit owned,” says MAPS Director of Strategy Fede Menapace

New Partnership to Bring Novamind’s Psychedelic Therapies to Latin America

Meanwhile, Novamind has partnered with an early-stage Uruguay-based mental health company Bienstar Wellness Corp. to bring the first network of mental health clinics treating patients with psychedelic medicines to Latin America. “Partnering with local operators allows us to disseminate Novamind’s best practices and standard operating procedures globally, with minimal investment and managed risk,” said Novamind CEO and Director Yaron Conforti.

FDA Green Lights Cybin’s Psilocybin-Assisted Psychotherapy for COVID-19 Distress Trial

A new Phase 2 clinical trial evaluating psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-19-related distress has been given the go-ahead by the United States Food and Drug Administration (FDA). The trial will be conducted at the University of Washington and leverage Cybin’s EMBARK psychotherapy model.  

Tryp Therapeutics to Launch Phase 2a Study on Psilocybin and Fibromyalgia

The FDA this week also gave the green light to Tryp Therapeutics to proceed with its Phase2a trial evaluating the efficacy of the company’s oral formulation of synthetic psilocybin, TRP-8802, in combination with psychotherapy for fibromyalgia. In partnership with the University of Michigan, the trial is expected to commence in 2022 and will enroll 20 fibromyalgia patients.

Numinus Wellness Announces New Potency and Toxicity Tests for Psychedelics

Psychedelics-focused mental healthcare company Numinus Wellness announced this week that it had developed a new method for screening psychedelic mushroom compounds. In addition to screening for therapeutically active constituents, the company has also developed a psychedelic mushroom toxicity screen that can quickly identify various toxins and could be used beyond the psychedelic industry in poison control responses. 

PharmaTher Granted New Japanese Patent for KETABET

In patent news, psychedelics biotech company PharmaTher has been granted a new Japanese patent for KETABET: the company’s combination formula of ketamine and betaine anhydrous, which has demonstrated an ability to enhance antidepressant effects while reducing ketamine’s known side effects. The company has also been granted a patent for KETABET in Taiwan, and it expects current patent applications for the formula in the United States, Europe, Canada, Israel, and China, to be granted.

atai Life Sciences Solidifies Position as Majority Shareholder in Compass Pathways

In psychedelic business stock news, biopharmaceutical company atai Life Sciences has increased its ownership interest in Compass Pathways from 19.4% to 20.8%. The company says its equity stake increase is due to its confidence in Compass Pathways and the potential of COMP360 to address unmet medical needs. The announcement arrives the same week Compass released new data about that promising propriety psilocybin therapy. Building on topline data released last month, Chief Medical Officer Dr. Guy Goodwin explained that the therapy was generally well-tolerated by patients, despite some study participants experiencing adverse events.