Cognition Therapeutics disclosed a detailed Phase 3 program for its Alzheimer’s candidate zervimesine (CT1812) during the Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego. The program will run two six‑month, randomized, placebo‑controlled studies enrolling adults with mild‑to‑moderate Alzheimer’s disease who have low plasma p‑tau217 levels, a biomarker that the Phase 2 SHINE study identified as predictive of a robust therapeutic response. The primary efficacy endpoint will be the iADRS composite of ADAS‑Cog 13 and ADCS‑ADL, and participants will be eligible for an open‑label extension after the core studies.
The announcement follows an end‑of‑Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025, in which the agency approved the biomarker‑enriched design and gave a positive scientific opinion on the proposed Phase 3 plan. Cognition also plans to seek scientific advice from the European Medicines Agency (EMA) in February 2026 to align its U.S. and global regulatory strategies, a step that could streamline the eventual New Drug Application process.
The biomarker strategy is a key differentiator for zervimesine. In the Phase 2 SHINE study, patients with low plasma p‑tau217 experienced a 95 % slowing of cognitive decline compared with placebo, a result that underpins the enrichment approach for the Phase 3 trials. By selecting a population most likely to respond, Cognition aims to increase the probability of a statistically significant benefit while potentially reducing trial size and duration.
The Phase 3 plan represents a major milestone in Cognition’s development pipeline and has implications for the company’s resource allocation. The CEO noted that the firm is actively evaluating its investment in Alzheimer’s versus its dementia with Lewy bodies (DLB) program, a decision that could shape future funding and partnership opportunities. Cognition’s financial position remains solid, with $25 million in cash and $50 million in NIH grant funds that extend its runway into the fourth quarter of 2025, although the company continues to burn cash at a rapid pace as it advances the Phase 3 studies.
Lisa Ricciardi, CEO, said the FDA’s endorsement of the biomarker‑enriched design “reinforces our confidence in the clinical strategy and positions zervimesine as a strong candidate for disease‑modifying therapy.” Dr. Anthony Caggiano, Chief Medical Officer, added that the Phase 2 data “demonstrate the power of the p‑tau217 biomarker to identify patients who will benefit most from the drug.” The company will use the Phase 3 results to inform its regulatory submissions and to guide future development of both Alzheimer’s and DLB indications.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.