Cerevel Therapeutics Announces Positive Results in Emraclidine Ambulatory Blood Pressure Monitoring Trial
Data provide clear evidence that emraclidine does not induce an increase in blood pressure with chronic dosing in people living with schizophrenia
Emraclidine demonstrated a mean change from baseline in 24-hour ambulatory systolic blood pressure at week eight of -2.7 mmHg for 10 mg QD and -0.4 mmHg for 30 mg QD
Trial ruled out a 3 mmHg or greater increase in 24-hour mean systolic blood pressure for both doses of emraclidine based on the upper bound of the 95% confidence interval, per FDA guidance
Emraclidine was generally well-tolerated, with a side effect profile consistent with prior trials
Comprehensive Phase 2 program in schizophrenia on track to read out in 1H 2024
CAMBRIDGE, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today results from the Phase 1 randomized, double-blind trial studying the effect of emraclidine on 24-hour ambulatory blood pressure over an eight-week period in people living with schizophrenia. The objective of the trial was to accurately characterize any potential blood pressure effect for both doses of emraclidine studied (10 and 30 mg QD).
On the primary endpoint, emraclidine demonstrated a mean change from baseline at week eight in 24-hour ambulatory systolic blood pressure (SBP) of -2.7 mmHg for the 10 mg QD group and -0.4 mmHg for the 30 mg QD group. The upper bound of the two-sided 95% confidence interval for the change from baseline at week eight was -0.3 mmHg for the 10 mg QD group and 2.1 mmHg for the 30 mg QD group. As a result, the trial ruled out an increase in blood pressure for both doses (defined per FDA guidance as >3 mmHg change from baseline). The secondary endpoints of the trial demonstrated findings consistent with the primary endpoint, corroborating the overall trial results. Emraclidine was generally well-tolerated in this trial, with a side effect profile consistent with prior trials.
“These results provide another example of Cerevel’s disciplined approach to drug development and validate the potential of emraclidine to be a transformative treatment for people living with schizophrenia,” said Tony Coles, M.D., chairperson and chief executive officer of Cerevel Therapeutics. “As a trained cardiologist, I am pleased that these results clearly support our conclusion that emraclidine does not cause a change in blood pressure when dosed in schizophrenia patients. Our comprehensive Phase 2 clinical program is well underway, as we seek to bring this much-needed new treatment option to people living with schizophrenia as quickly as possible.”
This ambulatory blood pressure monitoring trial was designed in line with FDA guidance (Assessment of Pressor Effects of Drugs, Guidance for Industry) to provide an accurate characterization of any potential sustained pressor effects of emraclidine over 24 hours of ambulatory monitoring in adults between the ages of 30- and 60-years old living with schizophrenia. Trial participants were evaluated at two doses, 10 mg QD and 30 mg QD, and the change from baseline to week eight, the primary endpoint, was assessed independently for each dose.
Emraclidine is a positive allosteric modulator designed to selectively target the M4 muscarinic receptor subtype. Emerging evidence suggests that activation of M4 muscarinic acetylcholine receptor subtypes can reduce striatal dopamine signaling and reduce psychotic symptoms, without blocking dopamine receptors. Current pharmacologic treatments for schizophrenia primarily target excessive striatal dopaminergic signaling by directly antagonizing postsynaptic dopamine D2 receptor subtypes.
In June 2022, Cerevel initiated its Phase 2 development program evaluating emraclidine in schizophrenia in two adequately-powered, placebo-controlled trials, known as EMPOWER-1 and EMPOWER-2. These trials are expected to read out in the first half of 2024. In September 2022, the company also initiated EMPOWER-3, a 52-week open-label safety extension trial, in order to accelerate a potentially registrational package for emraclidine in schizophrenia.
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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