Clinical-stage biopharmaceutical company Cerevel Therapeutics Holdings Inc. (CERE:NASDAQ), which concentrates if efforts on the treatment of 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."
Cerevel Therapeutics stated that in the Phase 1b trial, CVL-231 was shown to be well tolerated with discontinuation rates matching those of the control group after a six-week period of treatment. The company emphasized that in the study both the once-daily 30 mg and twice-daily 20 mg dosages demonstrated "clinically meaningful antipsychotic activity." Based upon the Positive and Negative Syndrome Scale (PANSS), patients receiving the once-daily 30 mg dose achieved a mean reduction in the PANSS score of 12.7 points and those who were given the twice-daily 20 mg doses achieved a 17.9-point reduction on average compared to the placebo group.
The firm advised that results obtained in the study provide support for advancing CVL-231 into a Phase 2 schizophrenia program. The company noted that that in addition it intends to investigate other additional related indications and, in particular, dementia-related psychosis.
John M. Kane, M.D., professor and chairman of the Department of Psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, stated, "We believe these results are impressive and provide important evidence for the specific activation of the M4 receptor as a potential treatment approach for schizophrenia…By selectively targeting the M4 receptor, CVL-231 appears to have yielded a robust and clinically meaningful antipsychotic effect while avoiding both the debilitating extrapyramidal side effects commonly seen with dopamine antagonists, as well as the serious gastrointestinal side effects that have limited non-selective muscarinic compounds in the past."
The firm stated that "CVL-231 is an M4-selective PAM being developed as a potential treatment for schizophrenia," that is designed for the purpose of reducing dopaminergic activity without direct dopamine receptor antagonist activity.
Cerevel Therapeutics' Chief Scientific Officer John Renger, Ph.D., commented, "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…By developing a molecule that is several hundred times more selective for M4 receptors over M1, M2, M3, and M5 receptors, we are expanding our understanding of how to best leverage the potential of the muscarinic pathway to effectively treat individuals with schizophrenia, with fewer of the dose-limiting side effects that occur with currently available therapies."
The company's Chief Medical Officer Raymond Sanchez, M.D., stated, "Novel approaches for treating schizophrenia have been challenging to identify for decades, and patients and caregivers are seeking new therapies without the debilitating side effects that lead to poor compliance and relapse…We are working to develop CVL-231 to be a once-daily formulation with improved tolerability, and without the need for titration, which could potentially improve adherence and avoid the vicious cycle of relapse with the exacerbation of symptoms so often seen with this illness."
Cerevel's Chair and CEO Tony Coles, M.D., remarked, "Consistent with the scientific approach we have taken across our broad neuroscience portfolio, CVL-231 leverages our differentiated understanding of neurocircuitry and the power of targeted receptor selectivity in the development of innovative medicines for patients in need…We are extremely encouraged by the data from this trial and believe CVL-231 has the potential to be a truly transformative therapy in schizophrenia."
The company explained that "schizophrenia is a serious, complex and debilitating mental health disorder characterized by a constellation of symptoms, including delusions, hallucinations, disorganized speech or behavior, slowed speech and blunted affect." The report noted that individuals diagnosed with the disease often suffer from serious cognitive impairment which not only effects their interactions with others, but also results in reduction in life expectancy of 10 to 25 years versus the general population.
Cerevel Therapeutics is a clinical-stage biopharmaceutical company headquartered in Cambridge, Mass., that focuses its efforts on the treatment of treat neuroscience diseases. The company stated that it takes a targeted approach to address these diseases using its expertise in neurocircuitry with a focus on receptor selectivity. The firm noted, "it combines understanding of the biology and neurocircuitry of the brain with advanced chemistry and central nervous system (CNS) receptor pharmacology to discover and develop new therapies." The company indicated that its current product development pipeline includes five clinical-stage investigational therapies and several preclinical compounds that are being tested to treat several diverse neuroscience diseases including epilepsy, Parkinson's, schizophrenia, and substance use disorder.
Cerevel Therapeutics started the day with a market cap of around $1.6 billion with approximately 127.5 million shares outstanding and a short interest of about 2.8%. CERE shares opened 60% higher today at $20.16 (+$7.59, +60.38%) over yesterday's $12.57 closing price and reached a new 52-week high this morning of $28.88. The stock has traded today between $19.05 and $28.88 per share and is currently trading at $28.34 (+$15.77, +125.46%).[NLINSERT]
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