Shares of Cerevel Therapeutics (NASDAQ: CERE) have surged premarket on Tuesday after the company reported positive results from its Phase 1b clinical trial of CVL-231 in adult patients with schizophrenia.
Cerevel said 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.
“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 company said in a statement.
The CVL-231 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 group.
The CVL-231 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 total score compared with the placebo group (p=0.047).
“We are extremely encouraged with these results, which we believe support our hypothesis that a targeted muscarinic therapy that is highly selective for M4 receptors could deliver clinically meaningful benefit in the treatment of schizophrenia,” said John Renger, chief scientific officer at Cerevel.
Additionally, CVL-231 was generally well-tolerated in the clinical trial.
The company feels the results support the advancement into a Phase 2 trial, while they also plan to explore additional related indications, including dementia-related psychosis.
Cerevel's share price is up 51% premarket at $19.
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