Clinical TrialJul 27, 2026, 07:02 AM
MapLight ML-007C-MA Phase 2 trial meets primary endpoint in schizophrenia
AI Summary
MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA for acute exacerbation of schizophrenia. The 210/3 mg BID dose met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in PANSS total score compared to placebo. The trial also showed robust improvement in cognitive performance and a favorable tolerability profile. The company plans to engage with the FDA for an End-of-Phase 2 meeting to discuss the path forward for a registrational Phase 3 trial.
Key Highlights
- ML-007C-MA 210/3 mg BID met primary endpoint in Phase 2 ZEPHYR trial for schizophrenia.
- Demonstrated a 4.5-point mean improvement in PANSS total score vs. placebo (p=0.015).
- Showed cognitive performance improvement (ES=0.51, p=0.041) in patients with baseline cognitive impairment.
- Achieved significance on key secondary endpoints including CGI-S (ES=0.48, p=0.002).
- ML-007C-MA was generally well tolerated with low GI-related discontinuations (2.0%).
- Company plans to engage with FDA at an End-of-Phase 2 meeting to discuss Phase 3 trial design.
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