- Cerevel Therapeutics Holdings Inc CERE has announced results from its Phase 1b trial of CVL-231 in adult patients with schizophrenia.
- CVL-231 was generally well-tolerated, and discontinuation rates were similar between CVL-231 and placebo in the six weeks of dosing, at 22% each.
- Notably, both the 30 mg once-daily and the 20 mg twice-daily doses demonstrated clinically meaningful antipsychotic activity with an overall well-tolerated profile compared with placebo.
- The 30 mg once-daily dose resulted in a statistically significant and clinically meaningful mean reduction from baseline of 19.5 points in the Positive and Negative Syndrome Scale (PANSS) total score and a mean reduction of 12.7 points in PANSS versus the placebo.
- The 20 mg twice-daily dose resulted in a statistically significant and clinically meaningful mean reduction from baseline of 17.9 points in PANSS total score and a mean reduction of 11.1 points in PANSS versus placebo.
- CVL-231 is an M4-selective PAM being developed as a potential treatment for schizophrenia.
- Additional data from the trial will be presented at an upcoming scientific meeting.
- Cerevel will host a conference call and webcast today at 8:30 a.m. ET to discuss the results of the Phase 1b trial of CVL-231 in schizophrenia.
- Price Action: CERE shares are up 29.7% at $16.30 during the premarket session on the last check Tuesday.
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