MindMed, a company specializing in psychedelic medicine, has released an independent report that validates its clinical and regulatory plan for its proprietary LSD compound, MM-120. The report was made by former officials of the FDA and was led by third-party firm, Greenleaf Health Inc. According to the report, MindMed’s ongoing Phase 2b trial is “well-designed” and “essential” to the development program of MM-120 for General Anxiety Disorder (GAD). FCM Holdings, a shareholder group, has been calling for skipping the Phase 2 stage to speed up the process, but the report deems that proposal unrealistic, saying it would risk investments.
Based on the report, MM-120’s program will require at least one, and likely two, “positive, adequate and well-controlled” trials to apply for FDA approval. Therefore, the dose-ranging Phase 2b study has been deemed appropriate and sound from a clinical and regulatory perspective. The report emphasizes that skipping “important learnings” from the Phase 2b trial, including preliminary evidence of efficacy, dose-response, and target population, would increase the chances of unsuccessful or uninterpretable results. The CEO and director of MindMed, Robert Barrow, reaffirmed that MindMed’s current regulatory strategy for MM-120 is the right approach, emphasizing that it was developed over multiple interactions with the FDA.
Barrow said that the ongoing Phase 2b trial maximizes the speed, efficiency, and probability of success of the Phase 3 program, and that FCM’s claims have no credible basis. Furthermore, he emphasized that MindMed’s shareholders support FCM’s claim, which would put not just MM-120’s future, but also their investments, at significant risk.
The report can be found here.
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