Cognition Therapeutics Aligns With FDA On Phase 3 Design For Alzheimer's Drug Zervimesine, Paving Way For NDA Filing

- Cognition and FDA align on enriched population, study design, and endpoints -

PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of-Phase 2 meeting that was conducted on July 9, 2025. FDA confirmed the proposed design of the Phase 3 program may support a New Drug Application (NDA) filing for zervimesine (CT1812) as a treatment for Alzheimer's disease.

Based on the FDA's feedback, the Phase 3 program is expected to enroll adults with a diagnosis of mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening. Previous clinical experience* has shown that zervimesine can arrest cognitive deterioration in this population by 95% compared to placebo. This degree of cognitive preservation in zervimesine-treated patients supports plasma p-tau217 as a predictive biomarker of robust treatment effect. Screening for p-tau217 levels in Phase 3 will therefore enrich the study population with patients most likely to benefit from zervimesine treatment.