Cognition Therapeutics' Proof-of-Concept Phase 2 SHINE Trial Demonstrates Consistent Improvement in Cognitive Outcomes with Once-Daily Oral CT1812 in Mild-to-Moderate Alzheimer's Patients

Core Insights - Cognition Therapeutics, Inc. reported positive results from the Phase 2 'SHINE' study of CT1812, showing cognitive improvement in participants treated for six months compared to placebo across various cognitive measures [1][9][12] - The study demonstrated a favorable safety and tolerability profile, with most treatment-related adverse events being mild or moderate [10][12][18] - CT1812 showed significant changes in neurofilament light chain, a marker of neurodegeneration, particularly at the 300mg dose [2][12] Study Details - The SHINE study enrolled 153 adults with mild-to-moderate Alzheimer's disease, randomized to receive either placebo or one of two doses of CT1812 (100mg or 300mg) [18][22] - The primary endpoint was safety and tolerability, while the key secondary endpoint focused on cognitive measures, specifically ADAS-Cog 11 [22] - Participants in the placebo arm experienced a decline of approximately 2.70 points on ADAS-Cog 11, while those treated with CT1812 declined by an average of 1.66 points, indicating a 39% slowing of decline [18][22] Clinical Implications - The results suggest that CT1812 may serve as a monotherapy or in combination with approved drugs for treating Alzheimer's disease and related dementias [9][12] - The findings from the SHINE study will inform future clinical trials and dose selection for CT1812 [9][12][12] - The company is also conducting additional studies, including the SHIMMER trial for Lewy body dementia and the START trial for early-stage Alzheimer's disease [11][23] Safety Profile - The overall percentage of participants experiencing any adverse event was similar between CT1812 treatment arms (76.5%) and the placebo group (78%) [10][12] - Serious adverse events were reported in 6% of CT1812-treated participants compared to 10% in the placebo group [19] - Treatment-emergent liver function test (LFT) increases were observed in the 300mg group but subsided after drug cessation without serious liver injury [3][10] Future Outlook - The company is optimistic about the SHINE results and anticipates further insights from ongoing trials [11][12] - Cognition Therapeutics has received over $170 million in grant support from various institutions, aiding its research and development efforts [11] - The company aims to advance CT1812 in clinical trials targeting neurodegenerative diseases, leveraging the distinct mechanism of action of the σ-2 receptor [24]