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MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA for…
MPLTMapLight Therapeutics, Inc.
MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA for schizophrenia. The 210/3 mg BID dose met the primary endpoint, demonstrating a statistically significant reduction in PANSS total score compared to placebo (effect size 0.37, p=0.015) at Week 5. The trial also showed significant improvement in a prespecified secondary cognitive performance endpoint (effect size 0.51, p=0.041). The drug was generally well tolerated with no serious or drug-related severe adverse events and a 19.9% all-cause discontinuation rate across active arms. The company plans to engage the FDA for an End-of-Phase 2 meeting to discuss a confirmatory Phase 3 trial to support an initial NDA submission. MapLight Therapeutics is a biopharmaceutical company developing treatments for central nervous system disorders.