Cerevel Therapeutics Initiates Phase 1b Clinical Trial of CVL-231, a M4 Selective Positive Allosteric Modulator in Development for the Treatment of Schizophrenia
- CVL-231 has the potential to be the first novel mechanism of action in schizophrenia in over two decades
BOSTON – October 21, 2019 – Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today it has dosed the first patient in a Phase 1b clinical trial evaluating CVL-231 in patients with schizophrenia.
“Too many people living with schizophrenia have difficulty managing their condition, which is why new therapies that target novel receptor pharmacology are desperately needed,” said John Renger, Ph.D., chief scientific officer of Cerevel Therapeutics. “CVL-231 is a potentially first-in-class antipsychotic designed to selectively modify the activity of the M4 muscarinic receptor to treat schizophrenia while reducing the side effects associated with currently available therapies.”
The double-blind, placebo-controlled Phase 1b study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of CVL-231. The trial will enroll up to 100 patients ages 18 to 50 with a primary diagnosis of schizophrenia.
“The initiation of our Phase 1b study of CVL-231 in patients with schizophrenia is an important milestone in our efforts to advance the clinical development of this novel compound,” said Raymond Sanchez, M.D., chief medical officer of Cerevel Therapeutics. “For the last 20 years, physicians who treat schizophrenia have been limited to standard-of-care therapies, which are associated with serious side effects that cause long-term health problems and hinders compliance. We look forward to evaluating CVL-231 in this multiple ascending dose trial.”
CVL-231 is a positive allosteric modulator (PAM) designed to selectively target the M4 muscarinic receptor. M4 muscarinic receptors have been shown to influence the levels of acetylcholine and dopamine, key neurotransmitters in the brain that are known to be dysregulated in diseases like schizophrenia.
Schizophrenia is a chronic, disabling neuropsychiatric disorder that affects 2.3 million people in the United States and 21 million people worldwide. Symptoms include hallucinations, delusions, disordered or disturbed thinking and behavior that impair daily functions, can be disabling, and generally requires lifelong treatment. Atypical antipsychotics are considered the current standard of care for treating schizophrenia but their use is hindered by significantly burdensome side effects, long-term morbidity, limited patient compliance and high relapse rates. With no cure or preventive measures available, new treatment options are needed that address the psychotic and cognitive symptoms of the disorder and demonstrate an improved safety and tolerability profile over existing treatments.
About Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company seeks to unlock the science surrounding new treatment opportunities through understanding the neurocircuitry of neuroscience diseases and associated symptoms. Cerevel Therapeutics has a diversified pipeline comprising four 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 disorders. Headquartered in Boston, Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations or potential acquisitions. For more information, visit www.cerevel.com
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