Cognition Therapeutics Completes Enrollment in Phase 2 SHINE Study of CT1812 in Mild-to-Moderate Alzheimer's Disease

- Top-line results expected mid 2024 -
- Strong physician interest drove SHINE study completion -

PURCHASE, N.Y., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. CGTX, (the "Company" or "Cognition"), today announced that the last participant was randomized in the Phase 2 SHINE study (NCT03507790) of CT1812, the company's lead candidate for the treatment of age-related neurodegenerative diseases of the CNS and retina. A total of 153 adults with mild-to-moderate (MMSE 18-26) Alzheimer's disease were randomized to receive either placebo or oral doses of CT1812 (100 mg or 300 mg). Endpoints include safety, change in cognitive function, as measured by ADAS-Cog 11 and biomarker evidence of disease modification. Top-line results are expected in mid 2024 after the last participants have completed six months of treatment.

"Results of the SHINE trial will provide important information on safety, tolerability and cognitive effects of CT1812 in people with mild-to-moderate Alzheimer's disease, and these results will inform our plans for Phase 3 development," Lisa Ricciardi, president and CEO of Cognition Therapeutics stated. "Completing enrollment in the trial ahead of our 2023 target allows us to bring proof-of-concept results sooner and provides savings to our company. We couldn't have accomplished this without the support of the study participants and caregivers as well as our investigators and collaborators at the National Institute on Aging. We look forward to seeing the full study results in mid 2024."

An evaluation of the first 24 SHINE participants showed that those treated with CT1812 experienced a slowing of cognitive decline as measured by a three-point difference on the ADAS-Cog 11 scale compared to placebo. Overall, CT1812 was well tolerated and adverse events were balanced across treatment groups, consistent with the safety profile observed in previous clinical trials.

"Results from our initial clinical trials with CT1812 have shown evidence of target engagement, a positive effect on neurophysiological, anatomical and cognitive endpoints, and biomarker evidence of an impact on underlying disease processes," added Anthony Caggiano, MD, Ph.D., CMO and head of R&D at Cognition Therapeutics. "We are optimistic about these combined findings and are looking forward to analyzing the final SHINE results."

The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million.  

About the SHINE Study
The SHINE study is a double-blind, placebo-controlled Phase 2 clinical trial designed to enroll approximately 144 patients with mild-to-moderate Alzheimer's disease. Participants are evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which is taken orally daily for six months. Endpoints include safety, cognitive function as measured by the ADAS-Cog 11, a globally recognized cognitive scale, and biomarker evidence of disease modification.

About CT1812
CT1812 is an experimental orally delivered small molecule that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex. Preclinical and clinical data demonstrate that this binding results in the displacement of toxic Aβ oligomers. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer's disease progression.

Participants are currently being recruited in the SHIMMER study (NCT05225415) of CT1812 in adults with dementia with Lewy bodies; the START study (NCT05531656) of CT1812 in adults with early Alzheimer's disease; and the MAGNIFY study (NCT05893537) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration.

About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer's disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com 

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