MapLight says Phase 2 ZEPHYR trial shows ML-007C-MA cuts PANSS score in schizophrenia
MPLT•Safety and next steps
The drug was generally well tolerated, with no serious or drug-related severe adverse events reported.
MapLight plans an End-of-Phase 2 FDA meeting, moving toward an additional registrational trial intended to support an NDA submission.
Phase 2 ZEPHYR trial meets main goal
MapLight Therapeutics reported positive topline results from its Phase 2 ZEPHYR trial of ML-007C-MA in adults with an acute schizophrenia exacerbation.
The study met its main goal, showing a clinically meaningful improvement in overall schizophrenia symptoms versus placebo at the twice-daily dose.
Cognitive benefit seen in prespecified analysis
A prespecified analysis also showed improved cognitive performance in patients with baseline cognitive impairment, suggesting a benefit beyond symptom control.
