Cerevel Therapeutics Hosts Inaugural Virtual R&D Event to Review Darigabat (CVL-865) and Provide Overview of Key Preclinical Programs
Cerevel Therapeutics has announced that darigabat is now the international nonproprietary name for CVL-865, a Phase 2 GABA Positive Allosteric Modulator. The company is hosting a live R&D event to detail its ongoing Phase 2 trials for darigabat in drug-resistant focal epilepsy and acute anxiety. Cerevel plans to file U.S. IND applications in 2021 for its PDE4B and Kappa Opioid Receptor Agonist preclinical programs. Darigabat has been well-tolerated in previous trials, showing effectiveness in epilepsy treatment.
- Darigabat shows robust anticonvulsant activity in patients with photosensitive epilepsy, with six of seven patients demonstrating complete seizure suppression.
- Cerevel is advancing its pipeline with the expectation of U.S. IND filings for PDE4B and Kappa Opioid Receptor Agonist programs in 2021.
- Data from Phase 1 trials for acute anxiety are only expected in the second half of 2021, leading to potential delays in understanding its efficacy.
- Data from the REALIZE trial for darigabat in drug-resistant focal epilepsy will not be available until the second half of 2022.
Darigabat now the international nonproprietary name (INN) for CVL-865, a Phase 2 GABA Positive Allosteric Modulator
Company Expects to File U.S. IND Applications in 2021 for PDE4B and Kappa Opioid Receptor Agonist Preclinical Programs
Live webcast today from 9:00 to 11:00 a.m. EST
CAMBRIDGE, Mass., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, will host the first in a series of virtual R&D events today from 9:00 to 11:00 a.m. EST. In a live webcast, Cerevel will lead an in-depth discussion of darigabat, formerly CVL-865, its Phase 2 GABAA positive allosteric modulator (PAM) and provide an overview of the PDE4B inhibitor and kappa opioid receptor (KOR) agonist preclinical programs. Subsequent R&D events dedicated to additional portfolio programs will be announced at a future time.
Darigabat is currently being studied in two clinical trials, including the Phase 2 REALIZE trial evaluating the compound as an adjunctive therapy in adults with drug-resistant focal epilepsy and a Phase 1 proof-of-principle trial for acute anxiety in healthy volunteers. Data from the Phase 1 trial for acute anxiety are expected in the second half of 2021 and data from the REALIZE trial are expected in the second half of 2022. This event is intended to provide a detailed look at the science behind the current clinical program, with time for questions.
PDE4B and KOR agonist are two of the leading preclinical programs in Cerevel’s deep pipeline. U.S. IND filings for both programs are expected in 2021.
The live webcast and accompanying slides can be accessed on the investor relations section of the Cerevel Therapeutics website here. A replay will be available in the same section of the company’s website for approximately 90 days.
About Darigabat
Darigabat, formerly CVL-865, is a subtype selective positive allosteric modulator 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 trial 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 Phase 2 clinical trial, please visit https://realizestudy.com.
About Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Cerevel Therapeutics has a diversified pipeline comprising five 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 disorder. Headquartered in Cambridge, Mass., 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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Media Contact:
Kate Contreras
W2O
kcontreras@w2ogroup.com
Investor Contact:
Matthew Calistri
Cerevel Therapeutics
matthew.calistri@cerevel.com
FAQ
What is the new international nonproprietary name for CVL-865?
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