Cognition Therapeutics and FDA Align on Pivotal Trial Design for Zervimesine in DLB Psychosis

Regulation
โดย GlobeNewswire·Read original
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Cognition Therapeutics has reached alignment with the U.S. Food and Drug Administration on key aspects of a pivotal Phase 3 trial for zervimesine as a treatment for psychosis associated with dementia with Lewy bodies. The FDA agreed that DLB psychosis could be an approvable outcome, and the registrational program is expected to begin in mid-2027. The study will enroll DLB patients experiencing hallucinations and delusions, including those on stable off-label antipsychotics, and randomize them to receive 100 mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on using the neuropsychiatric inventory as a novel primary endpoint. Zervimesine would be the first long-term, durable treatment option targeting the underlying disease, addressing a critical unmet need given that no drugs are approved for DLB and off-label antipsychotics carry severe risks.

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FDA alignment on pivotal trial design for zervimesine in DLB psychosis, a critical regulatory milestone.

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