- Cognition Therapeutics (CGTX, Financial) successfully concluded an end-of-Phase 2 meeting with the FDA for Alzheimer's treatment candidate, zervimesine (CT1812).
- The meeting primarily reviewed Phase 2 'SHINE' study results and discussed the pathway for a potential Phase 3 program.
- The company anticipates receiving formal FDA feedback in August 2025 to solidify its development strategy.
Cognition Therapeutics, Inc. (CGTX), a clinical-stage biopharmaceutical company focused on neurodegenerative disorders, announced the successful completion of an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding their Alzheimer's disease treatment candidate, zervimesine (CT1812). Held on July 9, 2025, the meeting aimed to discuss the Phase 2 'SHINE' study results and requirements for proceeding to Phase 3.
CEO Lisa Ricciardi expressed optimism about the discussions with the FDA, noting that the company expects to receive the official minutes from the FDA by August 2025. This feedback will confirm the development pathway for zervimesine in treating Alzheimer's disease, potentially leading to a new drug application (NDA).
The SHINE study, a double-blind, placebo-controlled Phase 2 trial, enrolled 153 adults with mild-to-moderate Alzheimer's disease. It successfully met primary safety and tolerability endpoints, with cognitive and functional changes also assessed. The study was heavily supported by grants from the National Institute on Aging of the National Institutes of Health (NIH), totaling approximately $30 million.
Zervimesine, an investigational oral treatment, targets central nervous system diseases by interrupting toxic protein effects in the brain. If successful, it could represent a significant advancement in treating Alzheimer's disease and dementia with Lewy bodies.
