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Cerevel Therapeutics Announces First Patient Dosed in Phase 2 Trial of darigabat, an Investigational Therapy in Development for the Treatment of Epilepsy
BOSTON – October 6, 2020 – Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced dose administration for the first patient in the Phase 2 REALIZE trial of darigabat, an orally-administered investigational therapy currently in development as an adjunctive treatment in adults with drug-resistant focal onset seizures, the most prevalent seizure disorder in epilepsy.
“Nearly one-third of people experiencing focal onset seizures do not respond to currently available treatments, as many therapeutic options cause intolerable side effects such as sedation, cognitive and motor impairments, and potential for addiction in some cases. A novel anti-epileptic therapy that is welltolerated and appropriate for chronic use would be an invaluable addition to the treatment options available to these patients,” said Raymond Sanchez, M.D., chief medical officer of Cerevel Therapeutics. “Based on previous trials, darigabat has the potential to provide clinically meaningful activity with an attractive tolerability profile, and we look forward to demonstrating these benefits in the darigabat REALIZE trial.”
The randomized, double-blind, placebo-controlled, parallel group Phase 2 study will assess the efficacy, safety and tolerability profile of darigabat as an adjunctive treatment in patients with drug-resistant focal onset seizures. The multicenter trial will enroll approximately 150 adults aged 18 to 75. Patients will be randomized to one of three arms during a 13-week treatment period: a maintenance dose of 7.5 mg darigabat administered twice daily, a maintenance dose of 25 mg darigabat administered twice daily, or placebo. The primary outcome is a measure of the focal onset seizure frequency rate per week. Cerevel expects the data readout in the second half of 2022. Patients that complete the maintenance period have the option to enroll in an open-label extension study of darigabat.
darigabat is a subtype selective positive allosteric modulator (PAM) that targets GABAA receptors containing α2/3/5 subunits. It is structurally differentiated from classical benzodiazepines and minimizes activity at α1-containing receptors, which is believed to help mitigate many of the adverse events associated with benzodiazepines. To date, darigabat has been evaluated in 289 patients and healthy volunteers across nine clinical trials, with results showing it to be generally well-tolerated. A Phase 2 single-dose study demonstrated robust anticonvulsant activity in patients with photosensitive epilepsy (a type of epilepsy in which seizures are triggered by flashing lights), with six of seven patients treated with darigabat experiencing complete suppression of intermittent photic stimulation (IPS), a characteristic epileptiform discharge shown on electroencephalograms (EEGs). For more information about the clinical trial, please visit https://realizestudy.com/.
Approximately 65 million people worldwide suffer from epilepsy, according to the Epilepsy Foundation and the National Institute of Neurological Disorders and Stroke. Epilepsy, which affects people of all ages, is a spectrum condition with a wide range of seizure types and control, which vary from person to person. An estimated 60% of all patients with epilepsy experience focal onset seizures while the remainder are classified as having either generalized onset or unknown onset seizures. An estimated 30% of people with epilepsy fail to achieve seizure control despite the use of two or more antiepileptic drugs (monotherapy or in combination). These patients continue to experience uncontrolled breakthrough episodes, which negatively impact their quality of life, increase their risk of sudden unexplained death, and adversely impact their families.
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 five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, epilepsy, Parkinson’s disease, and substance use disorder. 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 cereveldev.wpengine.com.
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