Cognition Therapeutics Secures FDA Path Forward for Zervimesine Registrational DLB Psychosis Study
CGTX•Cognition Therapeutics completed a May 20 FDA meeting to review Phase 2 SHIMMER results for its oral zervimesine and discuss registrational study design and endpoints for dementia with Lewy bodies psychosis. The company expects formal FDA meeting minutes in June to confirm the path forward for late-stage program.
1. FDA Meeting Overview
On May 20 Cognition Therapeutics held a planned meeting with the FDA to review Phase 2 SHIMMER data for zervimesine and align on design and endpoints for a registrational study targeting dementia with Lewy bodies psychosis.
2. Phase 2 SHIMMER Study Details
The SHIMMER trial demonstrated strong efficacy signals and a favorable safety profile for once-daily oral zervimesine in DLB patients with psychosis, supporting advancement to a pivotal program.
3. Registrational Study Path Forward
Cognition and the FDA discussed key trial design elements, agreeing there is a clear path to initiate a late-stage registrational study pending formal documentation.
4. Next Steps and Timeline
The company anticipates receiving FDA meeting minutes in June, after which it will finalize the protocol and initiate preparations for the pivotal DLB psychosis trial.
