MindMed completes pre-IND meeting with the FDA for Project Lucy
Based on positive pre-IND meeting with the U.S. FDA, MindMed is now prepared to open an Investigational New Drug in August 2021.
NEW YORK — MindMed, a psychedelic medicine biotech company, announced on Dec. 14 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 provides regulatory clarity 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.”
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 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.