Cerevel Therapeutics Holdings Inc. reported positive results from its Phase 1b clinical trial of CVL-231, a novel muscarinic M4-selective positive allosteric modulator, in adults with schizophrenia. The medication was tested at two doses (30 mg once-daily and 20 mg twice-daily) for six weeks and compared to a placebo. Both doses demonstrated clinically meaningful antipsychotic activity.
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 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.
There were no meaningful differences in gastrointestinal side effects, extrapyramidal symptoms. or weight gain compared with placebo. The results of this trial support the advancement of CVL-231 into a Phase 2 program in schizophrenia. Cerevel plans to explore additional related indications including dementia-related psychosis.
This was reported by Cerevel Therapeutics on June 29, 2021.