Maplight Therapeutics, Inc. reports positive Phase II results for schizophrenia drug ML-007C-MA
Maplight Therapeutics, Inc. reported that its Phase II ZEPHYR trial of ML-007C-MA met its primary endpoint in schizophrenia, with the twice-daily regimen producing a statistically significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores versus placebo at five weeks. The twice-daily treatment also produced positive secondary and cognitive findings, including improvements in clinical severity and positive symptoms among impaired participants. While the once-daily regimen showed numerical separation from placebo, it did not achieve statistical significance on the primary measure. Chief Executive Officer Chris Kroeger expressed encouragement regarding the results, noting a robust signal for cognitive benefits that supports the drug's broader development in Alzheimer's disease psychosis. However, market reaction was mixed; shares fell over 66% as investors compared the drug's efficacy to Bristol Myers' Cobenfy. Analysts noted that while ML-007C-MA may have a smaller effect size than Cobenfy, it offers a superior tolerability profile with no fasting requirements and lower rates of common adverse events. The company plans to move forward with two confirmatory pivotal trials for schizophrenia and continues its VISTA study for Alzheimer's disease.