Cognition Therapeutics, Inc. announced a significant regulatory update for its lead candidate, zervimesine (CT1812). An End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for mild-to-moderate Alzheimer’s disease is scheduled for July 9, 2025.
During this meeting, Cognition will review the results of the Phase 2 'SHINE' study and discuss proposed plans for a Phase 3 program aimed at supporting regulatory approval for zervimesine in Alzheimer's disease. This marks a critical step towards advancing the AD program.
In parallel, based on positive Phase 2 'SHIMMER' study results in dementia with Lewy bodies (DLB), the company submitted an Investigational New Drug (IND) application and an application for Breakthrough Therapy Designation for zervimesine in DLB. Breakthrough Therapy Designation could expedite development and regulatory review for this serious condition.
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