Core Insights - Cognition Therapeutics is advancing its registrational program for zervimesine in mild-to-moderate Alzheimer's disease, having discussed the program design with the FDA during an end-of-Phase 2 meeting [1][2] - The Phase 3 program will focus on adults with mild-to-moderate Alzheimer's disease and lower plasma p-tau217 levels, which is expected to enrich the study population for zervimesine treatment [2][3] - The SHINE study demonstrated a 95% slowing of cognitive decline in participants with lower p-tau217 levels treated with zervimesine compared to placebo [3] - Cognition Therapeutics plans to align its global Alzheimer's disease registrational plans with the European Medicines Agency (EMA) [4] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [9] - Zervimesine (CT1812) is an investigational oral medication aimed at treating Alzheimer's disease and dementia with Lewy bodies, targeting the toxic effects of Aβ and ɑ-synuclein [5][9] - The company has received significant grant support, including approximately $30 million for the SHINE study from the National Institute on Aging [8] Clinical Study Details - The SHINE study was a double-blind, placebo-controlled Phase 2 trial involving 153 adults, which met its primary endpoints of safety and tolerability [7][8] - Participants were randomized to receive either placebo or zervimesine at doses of 100 mg or 300 mg daily for six months [8] - The Phase 3 studies may consist of two six-month trials with a 1:1 randomization to zervimesine or placebo, with efficacy measured using validated cognitive and functional scales [3] Future Plans - Cognition Therapeutics is actively evaluating its resources across dementia with Lewy bodies and Alzheimer's disease [4] - The company aims to conduct a scientific advice meeting with the EMA to ensure alignment on registrational plans [4]

Core Insights - Cognition Therapeutics, Inc. conducted a positive end-of-Phase 2 meeting with the FDA regarding zervimesine (CT1812) for Alzheimer's disease treatment [1][2] - The SHINE Study demonstrated safety and tolerability, meeting its primary endpoints with 153 participants [4] - Zervimesine has been adopted as the United States Adopted Name (USAN) for CT1812 [3] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [6] - The company is advancing zervimesine through various clinical studies, including ongoing trials for dementia with Lewy bodies and early Alzheimer's disease [6] Study Details - The SHINE Study was a double-blind, placebo-controlled Phase 2 trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease, assessing cognitive and functional changes [4] - The study received approximately $30 million in grant support from the National Institute on Aging [5] Drug Mechanism - Zervimesine is an investigational oral medication that targets the toxic effects of Aβ and ɑ-synuclein proteins associated with neurodegenerative diseases [2][6] - The drug aims to slow disease progression and improve the quality of life for patients suffering from Alzheimer's and dementia with Lewy bodies [2]