Cerevel Therapeutics to Present at 41st Annual J.P. Morgan Healthcare Conference and Provide Pipeline Update
Initiated Phase 1 healthy volunteer trial to support development of emraclidine in Alzheimer’s disease psychosis in Q4 2022; second potential indication as a once-daily treatment
Phase 2 proof-of-concept darigabat panic disorder trial to be initiated in Q2 2023
Multiple data readouts and cash runway into 2025 to support advancement of diverse pipeline of novel neuroscience drug candidates
Cerevel presentation to take place on January 10 at 8:15 a.m. PT/11:15 a.m. ET
CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, will present tomorrow, Tuesday, January 10 at 8:15 a.m. PT/11:15 a.m. ET at the 41st Annual J.P. Morgan Healthcare Conference. During the presentation, Cerevel chairperson and chief executive officer, Dr. Tony Coles, will review the Company’s lead programs and upcoming milestones. A question-and-answer session will follow the presentation.
“Cerevel continues to execute successfully in bringing forward our robust pipeline of neuroscience programs which aim to address devastating diseases such as schizophrenia, Alzheimer’s disease psychosis, epilepsy, panic disorder, and Parkinson’s disease,” said Tony Coles, M.D., chairperson and chief executive officer of Cerevel. “We have clear momentum in our clinical programs, and we look forward to bringing innovative new treatment options to patients who desperately need new solutions. We are encouraged by the opportunities across our pipeline, and we look forward to providing updates on our progress throughout the year.”
Leveraging its deep understanding of neurocircuitry and targeted receptor subtype selectivity, Cerevel is executing on its broad, diverse pipeline of novel neuroscience drug candidates.
Below are the latest updates for Cerevel’s lead programs.
Emraclidine: an M4-selective positive allosteric modulator (PAM) in development for schizophrenia and Alzheimer’s disease psychosis.
In June 2022, Cerevel initiated its Phase 2 program in schizophrenia, in which emraclidine is being studied as a once-daily medication without the need for titration.
Cerevel is conducting two adequately-powered placebo-controlled Phase 2 trials, known as EMPOWER-1 and EMPOWER-2. Data for both trials are expected in the first half of 2024.
The 52-week open-label safety extension trial, EMPOWER-3, also remains ongoing.
To support a potential registrational package for emraclidine in schizophrenia, Cerevel is prioritizing the completion of nonclinical and clinical pharmacology studies.
Cerevel recently announced positive data in a Phase 1 ambulatory blood pressure monitoring trial providing clear evidence that emraclidine does not induce an increase in blood pressure with chronic dosing in people living with schizophrenia.
To support development in a second potential indication for Alzheimer’s disease psychosis, Cerevel initiated a Phase 1 multiple ascending dose trial in the fourth quarter of 2022 to evaluate the safety, tolerability and pharmacokinetics of emraclidine in elderly healthy volunteers, 65-85 years old.
The FDA granted Fast Track designation for emraclidine for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis.
Darigabat: an α2/3/5-selective GABAA receptor PAM currently under development for epilepsy and panic disorder.
Cerevel is conducting the REALIZE trial, a Phase 2 proof-of-concept trial in focal epilepsy. Data is expected in mid-year 2023.
In a proof-of-principle photoepilepsy trial, darigabat demonstrated anticonvulsant activity comparable to lorazepam.
Cerevel also plans to initiate a Phase 2 proof-of-concept panic disorder trial in the second quarter of 2023.
Based on the positive topline results reported in February 2022 for the Phase 1 trial of darigabat in acute anxiety, Cerevel has selected panic disorder, which is the second most common anxiety disorder and can be the most debilitating, as the second indication for development for darigabat.
Tavapadon: a D1/D5 partial agonist currently in Phase 3 for the treatment of Parkinson’s disease.
Tavapadon has the potential to be a first-in-class D1/D5 selective partial agonist for Parkinson’s disease, as both monotherapy and adjunctive treatment.
All three of Cerevel’s Phase 3 trials as monotherapy (early-stage) and adjunctive (late-stage) in Parkinson’s disease (TEMPO-1, -2, and -3) are ongoing, along with the corresponding open-label extension trial (TEMPO-4).
CVL-871: a D1/D5 partial agonist in development for treatment of dementia-related apathy.
Cerevel is conducting a Phase 2a exploratory trial in dementia-related apathy.
In addition to these lead programs, Cerevel is advancing its early clinical pipeline and discovery programs which include:
CVL-354, a selective kappa opioid receptor antagonist (KORA), for the treatment of major depressive disorder (MDD) and substance use disorder.
Selective M4 agonist program for the treatment of psychosis and other indications.
Selective PDE4 inhibitor (PDE4D-sparing) program for the treatment of MDD and schizophrenia.
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.
About Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases with a targeted approach to neuroscience 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 preclinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia, and dementia-related apathy. 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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