Cognition Therapeutics confirms aligment with FDA on path for zervimesine

Cognition Therapeutics (CGTX) received final minutes from the FDA pertaining to the end-of-Phase 2 meeting that was conducted on July 9. FDA confirmed the proposed design of the Phase 3 program may support a new drug application filing for zervimesine 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 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. Participants will be randomized to either 100mg of oral zervimesine or placebo daily for six months. Efficacy and safety will be assessed, with endpoints affirmed by the FDA in the meeting minutes. Cognition also plans to include biomarker and imaging assessments in the Phase 3 program to support the clinical outcomes. Participants who complete either study will be eligible to enroll in an open-label extension study.