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.
Trial 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.
However, the twice-daily 210/3 mg dose 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.
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.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.