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    Maplight Therapeutics Says Phase 2 Zephyr Trial Of ML-007C-MA For Acute Exacerbation Of Schizophrenia Met Its Primary Endpoint, With 210/3 Mg Twice-Daily Dose, While 330/6 mg Once-daily Dose Missed Primary Endpoint

    Benzinga·07/27/2026 11:07:47
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    • The trial, designed and sized to support registration, met its primary endpoint, with the 210/3 mg BID dose demonstrating a statistically significant improvement in PANSS total score compared to placebo at Week 5 with an effect size of 0.37 (LS mean difference vs PBO -4.5, p=0.015)
    • Cognitive performance was improved (ES=0.51, p=0.041) in those with baseline cognitive impairment on a prespecified secondary endpoint
    • 210/3 mg BID dose also achieved significant separation on key secondary endpoints, including 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 at both doses studied, with no serious or drug-related severe adverse events and low rates of GI-related discontinuations
    • No fasting requirement and a one-dose titration support a tolerability profile expected to translate into real-world adherence
    • Data support proceeding with an additional trial, also designed to be registrational, to replicate this result; Company to engage with FDA at End-of-Phase 2 Meeting