Global Developments in Germany, Canada and Brazil
Germany has approved a large phase 2b study on psilocybin for treatment-resistant depression.
Dr. Gerhard Gründer, of the Central Institute of Mental Health Mannheim, will lead the study alongside the Department of Psychiatry and Psychotherapy at Charité Campus Berlin Mitte and the Mind Foundation.
The German Government is funding the trials with €2 million allocated from the Federal Ministry of Education and Research.
This represents the first significant milestone in psilocybin clinical research for depression in Germany since the 1970s.
In Canada, the government has allowed the first Section 56 exemption to grant psilocybin therapy to a non-palliative patient, Psilocybin Alpha reported. This is another milestone (and key legal precedent) in the country’s path towards federal decriminalization of the compound, just over three months after Minister of Health Patty Hajdu granted the first exception to four terminally-ill patients.
The treatment was provided by Dr. Bruce Tobin, founder of TheraPsil, an NGO working to allow legal access to psilocybin therapy in Canada.
In Brazil, the National Health Surveillance Agency (ANVISA) approved the use of Spravato, an esketamine nasal spray used to treat treatment-resistant depression and acute suicidal behavior. The drug was approved by neighbouring country Argentina last September.
Field Trip Opens First Psilocybin Clinic, Begins Observational Study
This will be the first Field Trip clinic to offer psilocybin treatment, leveraging the fact that mushroom truffles containing psilocybin are not criminalized in The Netherlands.
The company’s clinics in Toronto, Los Angeles and New York currently offer ketamine-based therapy.
Psilocybin remains a scheduled substance in Canada and the U.S.
On Thursday, the company also announced the launch of an observational study aimed at measuring the biometric effects of Field Trip’s ketamine-assisted therapies.
The study will be done via a partnership with Whoop, a company that manufactures fitness trackers that measure heart rate variability and sleep quality.
“The partnership with Whoop gives us the platform to more precisely measure and demonstrate how the ketamine-assisted therapies we are delivering through our Field Trip Health centers in North America (and soon our programs using truffles containing psilocybin in The Netherlands) can elevate not only one's mental health, but their physical health as well," said Ronan Levy, Field Trip’s Executive Chairman to Benzinga.
This Week’s Milestone Round
Octarine, a Danish biotech company developing biosynthetic psychedelics and cannabinoids, closed a $1.8 million seed round.
Danish State Growth Fund led the round. Cannabis veteran Bruce Linton also participated.
The company, which recently announced the successful biosynthesis of psilocybin from a genetically-modified version of yeast, will use the proceeds to obtain preclinical validation of its proprietary cannabinoid derivatives, also obtained through a novel biosynthesis method.
MindMed (NEO:MMED) (OTCQB:MMEDF) released financial results for the third quarter, which ended Sept. 30. Total assets were $23.7 million, including $18.2 million in cash. Net loss equaled $8.6 million for the quarter, and $21.4 million for the nine months ended September 30.
The company closed an October financing round with proceeds of $21.6 million. The company's cash reserves are currently $37.8 million.
The income will go into furthering the company's evaluation of new product candidates and psychedelic product research opportunities, supporting the existing product line of functional mushrooms, and other operational expenditures.
Awakn Life Sciences, a UK-based psychedelics research and training company led by Prof. David Nutt and Dr. Ben Sessa, announced the upcoming opening of its first ketamine-assisted therapy clinic, which is due to open in the British city of Bristol in January 2021.
Awakn stated plans to open several other clinics in London, Birmingham, Manchester and Brighton, as it establishes operations for the eventual roll out of psilocybin and MDMA-assisted therapies.