In the news
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 22, 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
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about the potential attributes and benefits of our product candidates and the format and timing of our product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.