Cerevel Therapeutics Announces Positive Topline Results for CVL-231 in Phase 1b Clinical Trial in Patients with Schizophrenia

CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) – Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced positive results from its Phase 1b clinical trial of CVL-231, a novel muscarinic M4-selective Positive Allosteric Modulator (PAM), 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. Importantly, 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 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 (p=0.023). 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). These results were further supported by clinically meaningful reductions in the PANSS Positive and PANSS Negative subscales.

https://www.globenewswire.com/news-release/2021/06/29/2254559/0/en/Cerevel-Therapeutics-Announces-Positive-Topline-Results-for-CVL-231-in-Phase-1b-Clinical-Trial-in-Patients-with-Schizophrenia.html

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The important bit :wink:

" No meaningful differences in gastrointestinal side effects, extrapyramidal symptoms or weight gain compared with placebo

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Great find @firemonkey . I hope this med gets through phase 3 at some point.

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@twinklestars brought this to our attention.

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This sounds too good to be true, just like every other medication they release.

It will likely be released and we’ll start seeing the real side effects.

Don’t get your hopes up.

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This is certainly an interesting one, but this is also phase 1B.

Karuna’s drug KARXT has passed phase 2 already though, so the mechanism at least seems to have good possibility.

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Apparently one person in the trial had increased heart rate and had to drop out. I think there’s more to it than that. I don’t think it’ll be very good.

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