July 27 (Reuters) – MapLight Therapeutics said on Monday its schizophrenia drug failed to show statistically significant symptom improvement in the once-daily dosing arm of a mid-stage trial, sending its shares tumbling 55% in premarket trading.
Here are the details:
• The company was testing ML-007C-MA, a combination of betovumeline and fesoterodine, in adult patients with schizophrenia experiencing an acute exacerbation of psychosis.
• Patients receiving the once-daily 330/6 mg dose did not show a statistically significant improvement in symptoms compared with placebo after five weeks, missing the trial’s main goal.
• Investors and analysts had been closely watching how the drug would measure up against Bristol Myers Squibb’s Cobenfy, a recently approved schizophrenia treatment dosed twice daily.
• Leerink Partners analysts said in a note last week that some investors viewed the once-daily regimen as a key way for the drug to differentiate itself from Cobenfy and other treatments in the market.
• The twice-daily 210/3 mg dose, however, met the trial’s main goal at five weeks versus placebo, along with several key secondary goals, including improvements in disease severity and positive schizophrenia symptoms.
• The drug was generally well tolerated, with no serious or treatment-related severe side effects reported, MapLight said.
• Schizophrenia and related psychotic disorders affect an estimated 0.25% to 0.64% of the U.S. population, and people with the condition lose an average of 28.5 years of life, according to the National Institutes of Health.
• The company said the data support an additional registrational trial and that it plans to discuss the next steps with the U.S. Food and Drug Administration.
• MapLight is also studying the drug in Alzheimer’s disease psychosis, with top-line results expected in the second half of 2027.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
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