MapLight reports positive schizophrenia drug trial results
- MapLight Therapeutics reported positive Phase 2 results for ML-007C-MA in adults with acute exacerbation of schizophrenia.
- The 210/3 mg twice-daily dose met the primary endpoint with a statistically significant reduction in PANSS total score versus placebo.
- MapLight said it plans regulatory discussions with the FDA and additional clinical trials, including a Phase 3 schizophrenia study.
MapLight Therapeutics NASDAQ:MPLT) reported positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA in adults with acute exacerbation of schizophrenia.
The 210/3 mg twice-daily dose achieved the primary endpoint by reducing PANSS total scores compared with placebo at Week 5, with an effect size of 0.37, LS mean difference of -4.5 and p-value of 0.015 in the modified intent-to-treat population.
“ML-007C-MA demonstrated statistically significant improvements across key measures of schizophrenia symptoms while maintaining a generally well-tolerated safety profile,” said MapLight Therapeutics management.
The company reported that the twice-daily dose also showed significant improvements in CGI-S scores, PANSS positive Marder factor results and cognitive measures among patients with baseline cognitive impairment, while serious or drug-related severe adverse events were not reported.
MapLight said ML-007C-MA was generally well tolerated, with gastrointestinal-related discontinuations of 2.0% at the twice-daily dose.
MapLight Therapeutics develops medicines targeting neurological and psychiatric conditions, including schizophrenia and Alzheimer’s disease psychosis.
The company said it plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration and conduct additional registrational trials, including a Phase 3 schizophrenia study and the ongoing VISTA trial in Alzheimer’s disease psychosis.
