Cerevel Therapeutics Holdings Inc. on Tuesday said the U.S. Food and Drug Administration granted fast-track designation to CVL-871, in development for the treatment of dementia-related apathy.
The Cambridge, Mass., company, which is focused on neuroscience diseases, said it plans to initiate screening in a Phase 2a exploratory trial in dementia-related apathy in the next few weeks, with data expected in the second half of 2022.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Cerevel said CVL-871 could be a potential treatment to address the symptoms represented by dementia-related apathy, such as social disengagement, diminished initiative and interest, and loss of emotion.
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