MapLight Therapeutics reported positive topline results from the Phase 2 ZEPHYR trial of ML-007C-MA in adults hospitalized with an acute exacerbation of schizophrenia. The 210/3 mg twice-daily dose met the primary endpoint, producing a statistically significant and clinically meaningful reduction in PANSS total score versus placebo at Week 5 in the modified intent-to-treat population, with an effect size of 0.37 and a 4.5‑point LS mean improvement (p=0.015). Among trial completers, the effect size was 0.50 with a 6.0‑point LS mean difference (p=0.002), and key secondary endpoints such as CGI‑S and PANSS positive factor also reached significance.
A prespecified cognitive composite endpoint in participants with baseline cognitive impairment showed an effect size of 0.51 (0.44‑point improvement vs placebo; p=0.041) without correlation to PANSS change, suggesting an independent cognitive benefit. ML-007C-MA was generally well tolerated, with no serious or drug‑related severe adverse events, all‑cause discontinuation of 19.9% across active arms, and low rates of GI‑related discontinuations and dose reductions. There were no observed urinary retention, metabolic, hepatic or movement‑related signals, and dosing requires no fasting and only a one‑step titration. MapLight plans an End‑of‑Phase 2 FDA meeting and an additional confirmatory pivotal trial in schizophrenia, while the ongoing VISTA study is evaluating the same 210/3 mg BID dose in Alzheimer’s disease psychosis, with topline results expected in the second half of 2027.
Filing Explained
The once-daily regimen missed the primary endpoint, while the drug remains investigational and unapproved.
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