Clinical TrialJul 27, 2026, 07:11 AM
MapLight's ML-007C-MA Phase 2 ZEPHYR trial meets primary endpoint
AI Summary
MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial for ML-007C-MA in schizophrenia. The 210/3 mg BID dose met the primary endpoint, demonstrating a statistically significant improvement in PANSS total score (effect size 0.37, p=0.015) and also showed clinically meaningful improvement in cognitive performance (effect size 0.51, p=0.041). The drug was generally well-tolerated with a favorable safety profile. These results support advancing ML-007C-MA into an additional confirmatory pivotal study, with plans to engage the FDA for an End-of-Phase 2 meeting.
Key Highlights
- ML-007C-MA Phase 2 ZEPHYR trial met primary endpoint with 0.37 effect size (p=0.015).
- 210/3 mg BID dose showed statistically significant improvement in PANSS total score.
- Cognitive performance improved with 0.51 effect size (p=0.041) in impaired participants.
- Significant separation on CGI-S (ES=0.48, p=0.002) and PANSS Positive Marder Factor (ES=0.39, p=0.012).
- ML-007C-MA was generally well-tolerated with no serious or drug-related severe adverse events.
- Company plans FDA End-of-Phase 2 meeting for Phase 3 trial design.
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