First Participant Dosed in Europe as Cognition Therapeutics Expand Phase 2 Alzheimer's Disease Clinical Trial of Oral CT1812
SHINE Study Expanded from USA to Include sites in Spain, the Netherlands, and Czech Republic
PURCHASE, N.Y., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX) (the “Company” or “Cognition”), announced that the Phase 2 SHINE clinical trial of CT1812, an experimental oral, once-daily capsule in development for mild-to-moderate Alzheimer’s disease, has been expanded into clinical sites in Spain, the Netherlands, and the Czech Republic. CT1812 is designed to modulate a key cellular receptor known as sigma-2 and block oligomers from binding to neurons, thus preventing their synaptotoxic effects. This new mechanism of action is fundamentally distinct from and complementary with that of anti-amyloid antibody-based immunotherapy, such as lecanemab.
Brain Research Center in Amsterdam, The Netherlands is the first European site to enroll participants in the Phase 2 SHINE study being conducted in approximately 144 individuals. Dr. Niels Prins, director of the Center stated, “We are committed to offering Alzheimer’s patients and their families access to innovative clinical trials, such as the SHINE study of CT1812. With our industry partners, we believe we can make inroads in development of new medicines to slow the progression of Alzheimer’s and related disorders.”
Anthony O. Caggiano, M.D., Ph.D., Cognition’s chief medical officer and head of R&D added, “We believe that the approach of targeting soluble oligomeric Aβ species has been validated by lecanemab findings announced earlier this year by Eisai and Biogen at CTAD 2022. However, unlike antibodies, which lower brain amyloid levels, CT1812 was designed to shield neurons from these toxic proteins.”
Results from initial trials with CT1812 provided evidence to support expansion of the clinical programs. In particular, positive trends were seen in cognition, MRI volumetric imaging and proteomic biomarkers:
- Slower decline in ADAS-cog vs placebo over six months
- Preservation of brain volume (composite) vs placebo with statistically significant (p<0.05) improvement in volume in three regions of interest
- Normalization of biomarkers associated with Alzheimer’s pathology
The SHINE study is supported by approximately $30 million in grant funding from the National Institutes on Aging (NIA).
“We are grateful for the continued support of the NIA to accelerate the clinical development of CT1812 and advance our understanding of σ-2 biology in both Alzheimer’s disease and dementia with Lewy bodies,” added Cognition president and CEO, Lisa Ricciardi. “We appreciate the sense of urgency shown by Dr. Prins and his colleagues at Brain Research Center Amsterdam, who worked diligently to expedite their site activation and enroll Europe’s first patient in the SHINE trial.”
About the SHINE Study
The SHINE study is a double-blind, placebo-controlled Phase 2 clinical trial designed to enroll up to 144 participants with mild-to-moderate Alzheimer’s disease. In addition to background therapies, participants will be randomized to receive either placebo or one of two doses of CT1812, taken orally daily for six months. Endpoints include safety and biomarker evidence of disease modification as well as cognitive function, as measured by the ADAS-Cog 11, a globally recognized cognitive scale. More information about the SHINE study may be found at www.shineADstudy.com. In the Netherlands, please visit Brain Research Center.
CT1812 is an oral small molecule designed to penetrate the blood-brain barrier and bind selectively to the sigma-2 (σ-2) receptor complex. 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.
CT1812 is an experimental candidate and has not been approved by the U.S. FDA or other regulatory agency. It is currently in development for mild-to-moderate Alzheimer’s disease in the SHINE study (NCT03507790) and dementia with Lewy bodies in the SHIMMER study (NCT05225415).
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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Cognition Therapeutics, Inc.
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