Truffle Report has compiled a roundup of major psychedelic business news stories from the week of January 3-7, making it easier for you to access these insights in one place.
MindMed Completes Phase 1 Trial for 18-MC
Psychedelic Drug Developer MindMed announced on Tuesday that it has completed the initial phase of clinical trials for its proprietary 18-MC compound. This non-hallucinogenic ibogaine derivative is intended for use in the treatment of opioid addiction.
Phase 1 of the trial was completed at a single site in Perth, Australia, and featured both single dose and multiple ascending dose protocols. These tested safety and efficacy, and ranged from between “4 and 325 milligrams twice per day (for one day; n=5 per arm) or doses between 2 and 90 milligrams twice per day (for up to 7 days, n=5 per arm)”, according to the published release. Results are expected in early 2022.
“This is an exciting milestone, and we look forward to announcing the results of our Phase 1 study in the coming months,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “The growing opioid crisis claims over 75,000 lives each year and impacts more than we’ll ever know. While ibogaine has been used and studied as a treatment for opioid addiction, its efficacy, while promising, has been overshadowed by significant safety concerns. Our proprietary molecule, 18-MC, has indicated an encouraging safety profile and preclinical efficacy data setting the stage for our Phase 2a proof-of-concept study in individuals undergoing opioid withdrawal. We expect to initiate this study in early 2022, which will evaluate the safety, tolerability and efficacy of 18-MC in mitigating the symptoms of opioid withdrawal.”
Psychedelic Business News: Field Trip to Apply for Psychedelic Patient Therapy Under New Special Access Program Amendments
Field Trip Health announced on Thursday that it intends to utilize recent amendments by Health Canada to the Special Access Program to begin applying for psilocybin and MDMA-assisted therapy on behalf of patients. Recent changes to the SAP allow doctors to seek treatments involving otherwise restricted drugs for patients with “serious or life-threatening” conditions.
Field Trip was among the 25 corporate and institutional stakeholders who contributed to the public commentary involved in Health Canada’s decision to revise the SAP.
“Since the opening of our first Field Trip Health Center in Toronto in 2020, we’ve helped people around the world experience relief from suffering and find joy, wonder and fulfilment through our psychedelic therapies,” said Hannan Fleiman, President of Field Trip. “With three locations in Canada, our team of highly experienced psychedelic therapists and physicians, many who have completed the MAPS training for MDMA-assisted therapies, along with the protocols and programs providing psilocybin-assisted therapies at our location in The Netherlands, we feel there is no organization in the world more qualified than Field Trip to help Canadians access the SAP for these life-changing therapeutics.”
Filament Approved for Microdose Formulation Trial
British Columbia-based Filament Health announced on Tuesday that it had received approval from Health Canada to commence a Phase 2 trial of it’s natural psilocybin drug candidate PEX010. With philanthropic funding from the Nikean Foundation, the trial will assess the safety and efficacy of low doses of the psilocybin analog in patients with persistent depression, and will be conducted by Dr. Rotem Petranker of the Canadian Centre for Psychedelic Science and Dr. Norman Farb at the University of Toronto.
The study will include 100 healthy subjects, and is scheduled to begin in Q1 of 2022.
“We are pleased to support this landmark Canadian trial through the donation of our standardized natural psilocybin,” said Filament Chief Executive Officer, Benjamin Lightburn. “Our team’s involvement in facilitating this trial is an important contribution to the spirit of psychedelic research. We have greatly enjoyed working with Rotem and his team, and look forward to continuing to closely collaborate on this trial. We are excited to learn about new applications for our drug candidates and to gather additional safety data.”
Psychedelic Business News: MindSet Collaborates with McQuade Center to Develop Psychedelic Medicines
On Wednesday, MindSet Pharma announced that it would be collaborating with the McQuade Center for Strategic Research and Development, with a strategic investment of the part of MSRD to support novel drug discovery.
MSRD is a member of the global Otsuka group of pharmaceutical companies which focuses on early-stage investment opportunities in potentially game-changing pharmaceutical treatments and products.
“It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.”
