MindMed Calls FDA Experts To Validate LSD Drug Development Strategy

In a new chapter of the management quarrel between MindMed MNMD executives and shareholder group FCM Holdings, the company has published an independent report by former senior FDA officials on its clinical and regulatory plan for proprietary LSD compound and lead drug candidate, MM-120.

Authored by third-party firm Greenleaf Health Inc. led by former federal officials, the document says the ongoing Phase 2b trial is both “well-designed” and “essential” to the development program of MM-120 for GAD and states that FCM’s proposal on skipping the Phase 2 stage is “unrealistic” and would risk investments.

In order to apply for FDA approval, the MM-120 program “will need at least one, and more likely two, positive, adequate and well-controlled trials,” it states. This is why the decision to first initiate a dose-ranging Phase 2b study “is appropriate and sound from a clinical and regulatory perspective.”

Further, authors believe the agency’s feedback on the proposed program “in no way suggests” it would accept a program that skips “important learnings” from Phase 2b trial -including dose-response, target population, preliminary evidence of efficacy on accepted FDA endpoints for anxiety and safety- toward moving directly to a large Phase 3 program.

“To initiate Phase 3 trials before these foundational issues have been adequately addressed would substantially increase the chances of a failed trial and/or uninterpretable results,” they stated, adding existing published results are not enough to support the program’s streamlining into Phase 3, which is the option FCM is pointing at.

CEO and director Robert Barrow says MindMed’s regulatory strategy for MM-120 is the right one and that it was formulated “over several interactions” with the FDA. 

“Our ongoing Phase 2b study answers critical clinical and regulatory questions that will enable us to maximize the speed, efficiency and likelihood of success of our Phase 3 program,” added Barrow, stating the report reinforces that “there is no credible basis for FCM’s misplaced claim” and underscores shareholders’ support to FCM as “putting not just the future of MM-120, but also their investments, at significant risk.”

Read the full report here.

Photo: Benzinga edit with photo by Flametric, aiyoshi597, Gisele Yashar, Bacsica and Freedomz on Shutterstock.