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MindMed Completes Pre-IND Meeting with FDA on Use of LSD in Anxiety Treatment
Psychedelic biotech firm MindMed announced the successful completion of a pre-investigational new drug (IND) meeting with the FDA on its development of LSD-assisted therapy for the treatment of an anxiety disorder.
MindMed said it plans to open the IND with the FDA in August, with a Phase 2b clinical trial evaluating experiential doses of LSD to treat an anxiety disorder.
“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,” MindMed co-founder and co-CEO J.R. Rahn said in a news release.
MindMed also announced findings from the preliminary data in its evaluation of the ibogaine derivative 18-MC. Its Phase 1 Multiple Ascending Dose and Single Ascending Dose study showed the drug to be safe at the doses tested, with no serious adverse events reported. As such, the company’s clinical team and its 18-MC medical director, Dr. Judy Ashworth, will continue dose escalation to gather data on higher dosing. Pending a review of data from that round of testing, MindMed plans to initiate a Phase 2a proof of concept study.
