Emraclidine is being developed as a potential once-daily treatment for schizophrenia without the need for titration

Data show clinically meaningful and statistically significant improvement with emraclidine in PANSS total score at six weeks and was overall well-tolerated compared with placebo

Results demonstrate selective targeting of the M4 muscarinic receptor subtype as a potential novel treatment approach for schizophrenia

Comprehensive Phase 2 development program in schizophrenia currently underway

CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today the publication of data from its Phase 1b clinical trial of emraclidine, a novel muscarinic M4 selective positive allosteric modulator, in adults living with schizophrenia in The Lancet.

In the Phase 1b trial, both treatment groups of emraclidine (assessing 30 mg once daily and 20 mg twice daily) demonstrated clinically meaningful and statistically significant improvements in assessments of symptom severity (Positive and Negative Syndrome Scale (PANSS) total score) and emraclidine was generally well-tolerated compared with placebo after six weeks of treatment.

“We believe the data from the Phase 1b trial published in The Lancet support the potential of emraclidine to be an important treatment option with a novel mechanism of action for people living with schizophrenia,” said John H. Krystal, M.D., Robert L. McNeil, Jr. Professor of Translational Research and Professor of Psychiatry, of Neuroscience, and Psychology, and chair of the Yale Department of Psychiatry at Yale School of Medicine. “Emraclidine demonstrated clinically meaningful and statistically significant antipsychotic effects with no meaningful differences in gastrointestinal adverse events, extrapyramidal symptoms or weight gain compared with placebo.”

“Current schizophrenia treatment options are often associated with debilitating side effects, including neuromotor effects, sedation, weight gain, metabolic abnormalities and an increased risk for heart disease. Unfortunately, these side effects have a negative impact on a person’s quality of life and functioning, and can lead to treatment discontinuation and relapse,” said Christoph Correll, M.D., author, professor of psychiatry at The Zucker School of Medicine at Hofstra/Northwell in New York and professor and chair of the department of child and adolescent psychiatry at Charité University Medicine in Berlin. “Based on the impressive findings from the Phase 1b trial, emraclidine, a potential treatment with a novel mechanism of action, may provide an alternative therapy for people living with schizophrenia that may help mitigate the vicious cycle of disease progression that has been driven, at least in part, by problems with tolerability of current treatment options.” 

“We are so pleased that the positive results of the Phase 1b trial have been published in this leading medical journal, The Lancet, underscoring the strength of Cerevel’s deliberate and differentiated scientific approach to bringing forward novel treatments to address devastating neuroscience diseases,” said Raymond Sanchez, M.D., author, chief medical officer of Cerevel Therapeutics. “Cerevel is rapidly advancing emraclidine as a potential treatment option for people living with schizophrenia and recently initiated its comprehensive Phase 2 development program.”

“By selectively targeting the M4 receptor subtype, emraclidine has demonstrated a potential novel treatment approach rationally designed to harness antipsychotic benefit with the goal of minimizing the side effects associated with non-selective muscarinic agents,” said John Renger, Ph.D., author, chief scientific officer, Cerevel Therapeutics. “This publication underscores our scientific leadership as we work tirelessly towards becoming the premier neuroscience company.”

Data from this trial were announced in June 2021, as well as at conferences including the American College of Neuropsychopharmacology 2021, the 2022 Congress of the Schizophrenia International Research Society, Psych Congress 2022 and the Neuroscience Education Institute Congress 2022.

Based on these positive results, in June 2022, Cerevel initiated its Phase 2 development program evaluating emraclidine in schizophrenia in two adequately-powered, placebo-controlled Phase 2 trials, known as EMPOWER-1 and EMPOWER-2, expected to read out in the first half of 2024. Recently, in order to accelerate a potentially registrational package for emraclidine in schizophrenia, the company also initiated EMPOWER-3, a 52-week open-label safety extension trial.

About the Phase 1b Trial Design
This two-part, phase 1b trial was designed to assess the safety and tolerability of emraclidine in people living with schizophrenia. The first part of the trial (part A) was a multiple ascending-dose design to establish safety, tolerability, and appropriate dosing based on pharmacokinetics. The second part of the trial (part B) assessed the safety and tolerability of emraclidine 30 mg once daily and 20 mg twice daily compared with placebo.

About Emraclidine
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.

About Schizophrenia
Schizophrenia is a serious, complex and debilitating mental health disorder characterized by a range of symptoms, including delusions, hallucinations, disorganized speech or behavior, slowed speech and blunted affect. Schizophrenia is also often associated with significant and progressive cognitive impairment, which further limits a patient’s ability to be gainfully employed and maintain relationships. As of 2019, approximately 24 million individuals are living with schizophrenia worldwide. The onset of schizophrenia typically occurs early in life, in the early to mid-20s, and often requires lifelong management for most people, with approximately 30% considered treatment resistant and 27% experiencing relapse while receiving treatment.^​Schizophrenia is a top-20 cause of disability and is associated with decades of potential years of life lost in some people. Comorbidities associated with both schizophrenia itself and associated pharmacological treatments, including cardiovascular disease, drug-induced movement disorders, diabetes, weight gain and obesity, can contribute to significant long-term negative health outcomes.

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.

Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about: the potential attributes and benefits of our product candidates; the format, timing and objectives of our product development activities and clinical trials, including the emraclidine Phase 2 program in schizophrenia, Phase 1 elderly healthy volunteer trial and other statements regarding the design of clinical trials and preclinical studies and the timing of initiation, completion and data readouts for clinical trials; the timing and outcome of regulatory interactions, including whether trials meet the criteria to serve as registrational; the ability to compete with other companies currently marketing or engaged in the development of treatments for relevant indications; the size and growth potential of the markets for product candidates and ability to serve those markets; and the rate and degree of market acceptance of product candidates, if approved. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: clinical trial results may not be favorable; uncertainties inherent in the product development process (including with respect to the timing of results and whether such results will be predictive of future results); the impact of COVID-19 and the post-COVID landscape on the timing, progress and results of clinical trials; our ability to recruit and enroll suitable patients in our clinical trials; whether and when, if at all, our product candidates will receive approval from the FDA or other regulatory authorities, and for which, if any, indications; competition from other biotechnology companies; uncertainties regarding intellectual property protection; and other risks identified in our SEC filings, including those under the heading “Risk Factors” in our Quarterly Report on Form 10-Q filed with the SEC on November 8, 2022 and our subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Media Contact:
Anna Robinson
Cerevel Therapeutics
anna.robinson@cerevel.com

Investor Contact:
Matthew Calistri
Cerevel Therapeutics
matthew.calistri@cerevel.com