December 14th, 2020
MindMed (NEO: MMED, OTCQB: MMEDF, DE: MMQ), a leading psychedelic medicine biotech company today announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for an anxiety disorder.
The successful completion of this engagement with the FDA is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. MindMed intends to open the IND with the FDA in August 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.
MindMed Co-Founder & Co-CEO J.R. Rahn said “The FDA is one of the most impactful organizations for regulated drug development globally. We look forward to working through the FDA pathway on psychedelic assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021.”
18-MC (Project Layla) Phase 1 Clinical Development Update
Preliminary data has been analyzed for MindMed’s addiction treatment program evaluating the ibogaine derivative 18-MC, which the company has named Project Layla. The preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well tolerated at the doses tested to date, and no Serious Adverse Events (SAEs) have been reported.
Based on the excellent safety profile observed to date, MindMed’s clinical team and 18-MC’s Medical Director, Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. Once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study. A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.
MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.
MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.