USFDAJun 24, 2026, 07:41 AM
Cognition Therapeutics Aligns with FDA on Zervimesine Pivotal Study
AI Summary
Cognition Therapeutics announced it received written feedback from the U.S. Food and Drug Administration (FDA) following a recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and aligned with the company on key aspects of a pivotal trial for Zervimesine (CT1812). The registrational program is expected to commence in mid-2027, with the company developing the Neuropsychiatric Inventory (NPI) as a novel primary endpoint for DLB psychosis.
Key Highlights
- FDA agreed that DLB psychosis could be an approvable outcome.
- FDA aligned with Cognition Therapeutics on key aspects of a pivotal trial for Zervimesine (CT1812).
- Registrational program for Zervimesine in DLB psychosis is expected to begin in mid-2027.
- Phase 3 study will enroll DLB patients with psychosis symptoms, including those on off-label antipsychotics.
- Company will work with FDA on using the Neuropsychiatric Inventory (NPI) as a novel primary endpoint.
- Zervimesine slowed progression of hallucinations and delusions by 89% in the Phase 2 SHIMMER trial.
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