Cognition Therapeutics received end-of-Phase 2 meeting minutes from the U.S. Food and Drug Administration, confirming alignment on a registrational path for zervimesine (CT1812) in Alzheimer’s disease, according to the company. The FDA approved the proposed Phase 3 study design as sufficient to support a future New Drug Application filing.
Based on the feedback, the Phase 3 trials will enroll adults with mild-to-moderate Alzheimer’s disease showing lower plasma p-tau217 levels at screening, aiming to enrich for patients most likely to respond to treatment. Previous clinical data indicated a 95% reduction in cognitive deterioration in this subgroup compared to placebo, supporting p-tau217 as a predictive biomarker.
The Phase 3 design includes randomized daily dosing of 100 mg oral zervimesine or placebo over six months, with endpoints, biomarker and imaging assessments affirmed by the FDA. An open-label extension will be available for study completers. The company said that the FDA agreed two six-month Phase 3 studies could support the New Drug Application.
