Psyched: MDMA On Health Canada's Radar, MindMed Seeks FDA Support For LSD, Numinus Buys Mindspace

Health Canada Considers MDMA And Psilocybin 'Special Access' Program

This week, Health Canada opened a public consultation on its “proposal to restore potential access to restricted drugs through the Special Access Program (SAP).”

The SAP allows healthcare professionals to request unapproved drugs for patients with serious or life-threatening conditions if other therapies have failed, aren’t suitable or are not available in Canada.

The proposal includes bringing MDMA and psilocybin back from a 2013 amendment to the Food and Drug Regulations that restricted these drugs, among others, to be part of the SAP.

If the once restricted drugs qualify again for the SAP, they would be treated as controlled substances, thus allowing healthcare professionals to request these drugs for patients.

The agency will be receiving public comments on the new amendment until Feb. 10.

Numinus Acquires Mindspace Wellbeing

Psychedelics Biotech company Numinus Wellness NUMI announced this week the acquisition of Mindspace Wellbeing, an organization that offers ketamine-assisted psychotherapy as well as other forms of treatment at three Montreal locations.

“This is a first and major step forward in our plan for global expansion of revenue-generating clinics and virtual therapy with the objective of health and wellness for all," Numinus CEO Payton Nyquvest.

The acquisition adds a Montreal presence to Numinus’ existing Vancouver location. The deal was closed for approximately CA$3.7 million ($2.9 million).

On Thursday, the company also announced having successfully exercised its Health Canada License to extract psilocybin from naturally-produced psilocybe mushrooms.

"In the extraction process, Numinus Bioscience's goal is to optimize Psilocybe mushrooms to standardize psilocybin and multiple therapeutically important components, increasing the efficacy of the extract,” said Sharan Sidhu, Science Officer and General Manager.

Havn Life To Begin Preclinical Trial on Psilocybin For Inflammation

Havn Life Sciences HAVN has begun a preclinical trial to understand the effects of psilocybin on the immune system.

The company is launching a study to “determine if a single dose of psilocybin extract can impact the body's inflammatory response and regulate the human immune system.” The study is expected to begin in the first quarter of 2021.

“To date, minimal research has been done on psilocybin and its effects on human immunity, which is an area that has become more and more important,” said Vic Neufeld, Executive Chairman of Havn Life.

Executive Vice-President Susan Chapelle said that the findings could lead to significant discoveries in the treatments of inflammatory diseases such as pain, neuropathy and arthritis.

On Wednesday, the company also announced partnering with Complex Biotech Discovery Ventures, a cannabis R&D firm located at the Vancouver Campus at the University of British Columbia. The two companies will begin studying psilocybin under Havn Life’s Section 56 exemption, recently granted by Health Canada.

The study will help develop Havn Life's methodology for analyzing psilocybin mushrooms.

MindMed Completes Meeting with the FDA For LSD Research, Launches $50M Public Offering

MindMed MMED MMEDF has completed a pre-IND meeting with FDA for the development of LSD-assisted therapy for an undisclosed anxiety disorder.

Pre-IND (Investigational New Drug) meetings are a valuable step in the drug development path. These meetings allow applicants to refine applications for clinical trials and receive early FDA support.

MindMed expects to submit an application to launch Phase 2b clinical trials on LSD in August 2021.

In relation to the upcoming studies on LSD, the company announced a public offering of CA$50 million ($39.1 million). The proceeds will also be used to finance the company’s recently-launched digital medicine division, research on microdosing and research on 18-MC, a proprietary derivative of the hallucinogenic compound ibogaine.

This Week’s Milestone Round:

• Tryp Therapeutics debuted on the Canadian Securities Exchange under the symbol ‘TRYP.’ The company is focused on developing a type of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. About 17.4 million units of the company were made available at a price of CA$0.25 per unit, for gross proceeds of CA$4.3 million ($3.3 million).
• Eleusis purchased Kalypso Wellness Centers, a chain of ketamine-assisted therapy clinics with seven locations across the U.S. The purchase was done through an all-stock transaction for an undisclosed amount.
• Canadian cannabis extraction company Pure Extracts Technologies PULL announced plans to begin extraction of psilocybin through an application to Health Canada for a Dealer's Licence under the Controlled Drugs and Substances Act. The application has not yet been submitted.
• Ehave EHVVF announced the launch of KetaDASH, an intravenous-based, home delivery platform for patients who have been prescribed Ketamine. The platform will include software, staffing, protocols, and equipment to perform home administrations of ketamine-assisted therapy.
• Red Light Holland TRIP, in partnership with Disruptive Pharma, announced plans to enter the Brazilian market with Red Light’s line of “magic truffle” psilocybin products. Psilocybin is decriminalized in Brazil, a country with a population of 209 million. The parties signed a non-binding letter of intent to create a joint venture to cultivate, manufacturer, and commercialize magic truffles for the Brazilian market.