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Cerevel (CERE) Novel Schizophrenia Drug Succeeds in Phase I

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Cerevel Therapeutics Holdings (CERE - Free Report) stock skyrocketed 136.2% on Tuesday after the company announced positive data from an early-stage study, which showed that its targeted muscarinic therapy, CVL-231, can deliver clinically meaningful benefit in the treatment of schizophrenia, a mental health disorder.

The phase Ib study evaluated 30 mg once-daily and the 20 mg twice-daily doses of CVL-231, a novel muscarinic M4-selective positive allosteric modulator (PAM) in adult patients with schizophrenia. The data showed that in the six weeks of dosing, both the doses of the candidate achieved clinically meaningful antipsychotic activity with an overall well-tolerated profile compared with placebo.

The 30 mg dose of CVL-231 once-daily improved PANSS (Positive and Negative Syndrome Scale) total score, a rating instrument for patients with schizophrenia, at 6 weeks by 12.7 points (mean reduction) compared with placebo. Meanwhile, the 20 mg of CVL-231 twice-daily improved PANSS total score at 6 weeks by 11.1 points compared with placebo. The discontinuation rates for both CVL-231 and placebo were 22% each.

Cerevel’s stock has risen 79.1% this year so far against a decrease of 8.4% for the industry.

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Overall, the study data showed that this candidate, which has a novel approach for treating schizophrenia, yielded a robust and clinically meaningful antipsychotic effect by selectively targeting activation of the M4 receptor in the brain. At the same time, CVL-231 avoided gastrointestinal, extrapyramidal, and metabolic side effects seen with other currently available antipsychotic medications, which lead to poor compliance and relapse. The company feels CVL-231 has the potential to be a transformational therapy in schizophrenia

Based on data from the study, Cerevel plans to proceed CVL-231 into a phase II program in schizophrenia.

We remind investors that Cerevel was spun off from Pfizer (PFE - Free Report) in 2018 and started trading on Nasdaq from October 2020.

Another important novel schizophrenia candidate in development is Karuna Therapeutics (KRTX - Free Report) KarXT, M1/M4-preferring agonist, which is currently in phase III development for the treatment of psychosis in adults with schizophrenia. Minerva Neurosciences (NERV - Free Report) is also developing its lead pipeline candidate, roluperidone, as a potential treatment for negative symptoms of schizophrenia in phase III.

Cerevel currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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