MapLight精神分裂症二期试验QD剂量未达主终点，股价盘中暴跌逾六成

MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
The Zephyr trial enrolled 307 patients that were experiencing acute episodes of worsened psychosis and treated them with different doses of an M1/M4 muscarinic agonist called ML-007C-MA. Those given a twice-daily dose of 210/3 mg saw significant reductions in disease severity, hitting the primary endpoint, but those given a once-daily dose of 330/6 mg did not, MapLight announced today.
As a result, the biotech’s share price tumbled from $36.56 at Friday’s close to $13.76 at 10:30am E.T.
MapLight did shine light on some positive trends in the once-daily dose, noting that its performance on the primary endpoint was numerically better than placebo, though not statistically significant, and it outperformed placebo on some secondary measures too. The biotech is planning further analyses to decide how to move forward with the once-daily dose, according to the release.
On average, patients given ML-007C-MA twice a day saw their scores on the Positive and Negative Syndrome Scale (PANSS) drop by 4.5 points after five weeks compared to placebo. The treatment at both dose levels was generally well-tolerated, MapLight said, with one severe adverse event—a case of pneumonia—deemed unrelated to ML-007C-MA.
“We are very encouraged by these results, which show that ML-007C-MA delivered clinically meaningful antipsychotic efficacy alongside a favorable tolerability profile designed to translate into real-world use," Chris Kroeger, M.D., MapLight’s co-founder and CEO, said in the release.
Kroeger also highlighted that the twice-daily dose bested placebo on a measure of cognitive impairment, an effect that seems unrelated to its lowering of psychosis severity.
“Cognitive impairment affects the majority of people living with schizophrenia and remains an area where no therapy has yet been approved,” Kroeger said. Plus, he added, the finding should bode well for the ongoing phase 2 trial of ML-007C-MA in Alzheimer’s disease psychosis.
MapLight debuted on the Nasdaq last October with a $250 million initial public offering to raise funds for the Zephyr trial, all with the goal of taking on Bristol Myers Squibbs’ Cobenfy, which became the first new schizophrenia medicine in decades when it was approved in September 2024. The BMS drug has since had a relatively muted launch.
MapLight also boasts a phase 2 autism spectrum disorder candidate and a trio of preclinical programs in its pipeline, along with a development deal with Alphabet’s AI spinout SandboxAQ valued at more than $200 million.