MindMed Phase 2b MM-120 in GAD meets primary endpoint, 7.6-point HAM-A improvement vs placebo

Definium Therapeutics, Inc.

MM-120 100 µg achieved 21.3-point HAM-A reduction vs 13.7 placebo (p=0.0004, Cohen's d=0.88) at Week 4 after single dose.
Clinical response rate 78% (100/200 µg) and remission 50% (100 µg) at Week 4; CGI-S improved from 'markedly ill' to 'borderline'.
Well-tolerated with mostly mild-moderate AEs on dosing day; 97.5% completion in high-dose groups with no AE discontinuations.
Plans End-of-Phase 2 meeting with FDA in H1 2024 and initiation of Phase 3 program in H2 2024; 12-week data expected Q1 2024.

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