Cerevel Therapeutics Initiates Phase 1 Clinical Trial of CVL-936, an Investigational Medicine in Development to Treat Substance Use Disorder
January 30, 2020 at 08:00 am EST
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Cerevel Therapeutics announced that it has begun dosing healthy volunteers in a Phase 1 clinical trial of CVL-936, an orally-administered and potential first-in-class investigational therapy for the treatment of substance use disorder. An ongoing epidemic of substance use disorder is occurring in the United States, whether in the form of opioids, stimulants, alcohol, or nicotine, and the 20 million or more people who are affected are in dire need of new therapeutic options. For instance, despite existing treatments, approximately 90% of people living with opioid use disorder are estimated to relapse within five years, and it is estimated over half may relapse within the first six months,” said John Renger, Ph.D., chief scientific officer of Cerevel Therapeutics. The randomized, double-blind, placebo-controlled Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of CVL-936 in healthy volunteers ages 18 to 50. The trial will be conducted at a single center and will include up to 27 subjects across three cohorts. CVL-936: CVL-936 is a selective dopamine D3-preferring, D2/D3 receptor subtype antagonist in clinical development for the treatment of substance use disorder. It was designed to selectively block the binding of dopamine to D3 receptors on neurons located in the brain’s reward center, while reducing, but not fully inhibiting, signaling at D2 receptors. This therapeutic approach could help re-balance the dysregulation that takes place in the reward system in the brain during substance addiction and aid in the prevention of future relapse across drugs of abuse that short-circuit this system in patients. About Substance Use Disorder: Approximately 20.3 million people in the United States age 12 or older had a substance use disorder in 2018, according to results from the 2018 National Survey on Drug Use and Health.3 The disease affects a person's brain and behavior and leads to an inability to control the use of a legal or illegal drug or medication.3 Symptoms may vary between individuals but typically include behavioral changes, physical changes and social changes.4 Types of drugs associated with substance use disorder include but are not limited to heroin, oxycodone, methamphetamine, cocaine, benzodiazepines, alcohol, nicotine and ecstasy.
Cerevel Therapeutics Holdings, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on neuroscience that combines an understanding of disease-related biology and neurocircuitry of the brain with advanced chemistry and central nervous system (CNS) target receptor selective pharmacology to discover and design new therapies. It focuses on transform the lives of patients through the development of new therapies for neuroscience diseases, including schizophrenia, Alzheimerâs disease psychosis, epilepsy, panic disorder and Parkinsonâs disease. Its pipeline candidates include Emraclidine, Darigabat, Tavapadon and CVL-871. Emraclidine is a positive allosteric modulator (PAM), that selectively targets the muscarinic acetylcholine 4 receptor subtype (M4). Darigabat is a PAM that selectively targets the alpha 2/3/5 subunits of the GABAA receptor. Tavapadon is a selective dopamine D1/D5 receptor partial agonist that it is developing for the treatment of Parkinsonâs disease.