Cognition Therapeutics Aligns with FDA on Zervimesine Pivotal Study
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.
Price Impact
More from CGTX
Cognition Therapeutics gets FDA alignment for pivotal DLB psychosis trial
Cognition Therapeutics Receives Patent for Zervimesine, Extends Protection to 2045
Cognition Therapeutics Advances Zervimesine to Registrational DLB Psychosis Trial