MapLight精神分裂症二期ZEPHYR试验BID剂量达标但QD剂量未达主终点

MapLight Therapeutics (MPLT) announced positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA in adults with an acute exacerbation of schizophrenia. The trial met its primary endpoint, with the 210/3 mg twice-daily dose demonstrating a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale total score compared to placebo at week 5. ML-007C-MA also achieved significance on key secondary endpoints in the BID arm, including Clinical Global Impression of Severity, PANSS positive Marder factor, and multiple other secondary and exploratory outcomes. The 330/6 mg once-daily or QD dose, which results in lower daily exposure than BID dosing, demonstrated numerical improvement over placebo, but did not achieve statistical significance on the primary endpoint. The company is conducting further analyses to inform the potential path forward for a once-daily regimen.