Cerevel Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to CVL-871 for the Treatment of Dementia-Related Apathy
CAMBRIDGE, Mass., June 15, 2021 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CVL-871, a D1/D5 partial agonist in development for the treatment of dementia-related apathy.
“Apathy is a strong predictor of dementia progression and can lead to decreased quality of life, increased morbidity and mortality, early institutionalization, and significant caregiver burden,” said Raymond Sanchez, M.D., chief medical officer of Cerevel Therapeutics. “We believe that CVL-871 could be a potential treatment to address the constellation of symptoms represented by dementia-related apathy, such as social disengagement, diminished initiative and interest and loss of emotion, and we look forward to our continued collaboration with the FDA to advance the development of this important program through the Fast Track process.”
Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The designation allows for early and more frequent communication and meetings with the FDA regarding the development of CVL-871 for the treatment of dementia-related apathy. A candidate that receives Fast Track designation is also eligible for rolling review, and potentially priority review, of the marketing application.
About Dementia-Related Apathy
Apathy has been reported as the leading neuropsychiatric symptom in patients with dementia. The social disengagement and loss of emotion in apathy can lead to impaired decision-making, lack of empathy or concern, loss of interest in personal well-being and relationships, inability to initiate and maintain normal daily activities, as well as interference with basic daily functioning.
Apathy is among the most common neuropsychiatric co-morbidities associated with dementia, placing significant burden on both caregivers and families, and correlating very highly with disease progression. An estimated 6.2 million Americans aged 65 and older are living with dementias such as Alzheimer’s disease.1 Apathy affects approximately 50 percent of people with dementia.2
CVL-871 is a selective dopamine D1/D5 partial agonist specifically designed to achieve a modest level of partial agonism that may be useful in modulating the complex neural networks that govern apathy-related behaviors in neurodegenerative diseases. Cerevel submitted an Investigational New Drug application, or IND, to the FDA for CVL-871 in the first quarter of 2021 for the treatment of dementia-related apathy. Cerevel plans to initiate screening in a Phase 2a exploratory trial in dementia-related apathy in the next few weeks and data are anticipated in the second half of 2022.
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 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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1 Alzheimer's Association. (n.d.). Facts and Figures. Alzheimer's Disease and Dementia. https://www.alz.org/alzheimers-dementia/facts-figures#:~:text=An%20estimated%206.2%20million%20Americans,Americans%20with%20Alzheimer's%20are%20women.
2 World Health Organization. (n.d.). Dementia. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/dementia#:~:text=Worldwide%2C%20around%2050%20million%20people%20have%20dementia%2C%20with%20nearly%2060,is%20between%205%2D8%25.