other material
confidence high
sentiment positive
materiality 0.85
MapLight reports positive Phase 2 ZEPHYR results for ML-007C-MA in schizophrenia
MapLight Therapeutics, Inc.
- Primary endpoint met: 210/3 mg BID dose showed statistically significant PANSS total score reduction vs placebo (effect size 0.37, p=0.015, LS mean diff -4.5).
- Cognitive performance improved in patients with baseline impairment (effect size 0.51, p=0.041) on prespecified secondary endpoint.
- ML-007C-MA was well tolerated with no serious or drug-related severe adverse events; all-cause discontinuation low at 19.9%.
- Company plans End-of-Phase 2 FDA meeting and additional confirmatory trial to support NDA submission.
- Also reported positive IRIS Phase 2 results for ML-004 in autism irritability; plans FDA EOP2 meeting.