Cerevel Therapeutics announced positive results from its Phase 1b clinical trial of its novel muscarinic M4-selective Positive Allosteric Modulator (PAM) in adult patients with schizophrenia.
The clinical-stage biotech's stock surged following the successful data from the trial testing its lead drug candidate, CVL-231. In the early trial, both doses of the drug tested demonstrated a clinically meaningful and statistically significant improvement in PANSS Total score — the widely used measure of symptom severity in schizophrenia.
The big selling point came in the side effects, or lack thereof. By selectively targeting the M4 receptor, CVL-231 appears to have yielded a robust and clinically meaningful antipsychotic effect while avoiding both the debilitating drug-induced movement disorders commonly seen with dopamine antagonists, as well as the serious gastrointestinal side effects,
The Cambridge, Massachusetts-based Cerevel was founded in late 2018, backed by Pfizer research and supported by an initial capital commitment from an affiliate of Bain Capital and a keystone equity position from Pfizer. The company has a diversified pipeline comprising five clinical-stage investigational therapies and several pre-clinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia, and substance use disorder.
Cerevel plans to advance CVL-231 to phase 2 development in schizophrenia and to evaluate the potential for this mechanism in other populations, including dementia-related psychosis.
Read the press release
