Mind Medicine (MindMed) Inc (NEO:MMED) (OTCQB:MMEDF) (FRA:MMQ) announced Monday the successful completion of a pre-Investigational New Drug pre-IND) meeting with the US Food and Drug Administration (FDA) on the development of LSD-assisted therapy for an anxiety disorder.
In a statement, the company said the successful engagement with the FDA is an important milestone and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the US.
MindMed said it intends to open the IND with the FDA in August 2021 with a Phase 2b clinical trial (called Project Lucy) evaluating experiential doses of LSD in an anxiety disorder.
READ: MindMed launches digital medicine division Albert to weave together technology and psychedelics
“The FDA is one of the most impactful organizations for regulated drug development globally,” said MindMed Co-Founder & Co-CEO JR Rahn. “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.”
In other company news, MindMed said preliminary data has been analyzed for its addiction treatment program evaluating the ibogaine derivative 18-MC, which the company has named Project Layla.
The New York City-based company said preliminary data from the Phase 1 Multiple Ascending Dose and Single Ascending Dose study has shown that the drug is safe and well-tolerated at the doses tested to date, and no Serious Adverse Events reported.
Based on the excellent safety profile observed to date, MindMed said its 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 said it will directly 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.
The company’s stock recently traded 16% higher to $4.17 a share in New York.
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