Cognition Therapeutics Presents Scientific Rationale, Clinical Biomarker and Preclinical Data supporting a Phase 2 Clinical Trial with CT1812 in Geographic Atrophy Secondary to Dry AMD
Cognition Therapeutics (Nasdaq: CGTX) announced significant advancements regarding its Phase 2 trial for CT1812, targeting geographic atrophy due to dry age-related macular degeneration (dry AMD). With dry AMD affecting 10 million people in the U.S., the company emphasizes the need for effective treatments. CT1812, an oral sigma-2 receptor modulator, has shown promise in preclinical studies, demonstrating potential to rescue retinal pigment epithelial (RPE) functions impaired by oxidative stress. Cognition is in discussions with the FDA to initiate trials involving over 200 participants.
- CT1812 shows promise as a non-invasive oral treatment for dry AMD, a significant unmet medical need.
- Data from proteomic analyses and preclinical studies support the therapeutic potential of CT1812 in treating dry AMD.
- No approved drugs exist for dry AMD, indicating high competition and risk for trial success.
- The need for FDA discussions for trial initiation suggests potential regulatory hurdles.
PURCHASE, N.Y., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (Nasdaq: CGTX), (the “Company” or “Cognition”) today announced that the scientific rationale, supporting proof-of-concept data and design of the planned Phase 2 trial of CT1812 in geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD) will be communicated in an oral presentation at the 2022 Dry AMD Therapeutic Development Summit. Age-related macular degeneration is the leading cause of irreversible central vision loss in the world, with dry AMD affecting an estimated 10 million people in the U.S., 1.5 million of whom have advanced disease or GA.
“There are currently no approved drugs for dry AMD, and given the severe consequence of disease and enormous patient population, it’s imperative that we work towards a treatment,” added Lisa Ricciardi, president and CEO of Cognition Therapeutics. “Complement inhibition has shown potential in clinical trials but must be given via intravitreal injection to each affected eye. We believe that a noninvasive oral therapeutic with a novel mechanism of action that can penetrate the blood-retina barrier and treat both eyes simultaneously would be a significant advantage to the millions of people at risk for permanent vision loss.”
CT1812 is an experimental oral sigma-2 (σ-2) receptor modulator currently in Phase 2 clinical trials for both Alzheimer's disease and dementia with Lewy bodies (DLB). An unbiased pathway analysis from two Alzheimer's disease clinical trials identified GA and macular degeneration as two diseases most significantly associated with proteomic changes in CT1812- vs placebo-treated patient biofluids. Further analysis of the proteomes identified key proteins and pathways impaired in dry AMD and GA that were significantly impacted by CT1812 treatment, providing evidence that a σ-2 receptor modulator may have therapeutic potential in dry AMD.
Subsequently, in vitro studies were conducted using RPEs derived from induced pluripotent stem cells (iPSC) that were exposed to amyloid beta oligomers and oxidative stress. Results from these studies demonstrated that administration of CT1812 can rescue the ability of RPEs to recycle photoreceptor outer segments (POS), a vital process that is damaged by stressors including oxidative stress and pathogenic proteins.
“The proteomic analyses from our clinical studies in neurodegenerative disease were instrumental in identifying dry AMD as an indication of interest,” explained Mary Hamby, Ph.D., VP of biology at Cognition Therapeutics. “Published genetic and preclinical findings from independent laboratories supported the role of the σ-2 receptor in dry AMD and our data provide evidence that modulation of the σ-2 receptor may protect sensitive RPE cells and rescue functional deficits. Our next step is to test this novel mechanistic approach in the clinic.”
Based on several lines of evidence including these clinical proteomic analyses and preclinical data in RPE cell models, Cognition has entered discussions with the U.S. Food and drug Administration (FDA) to initiate a Phase 2 clinical trial in over 200 people with GA. The full complement of evidence supporting Cognition's advancement of CT1812 into the clinic, along with the design of the proposed Phase 2 study, will be presented at the Dry AMD Therapeutic Development Summit.
Presentation details:
| Date/Time: | December 1, 2022 | |
| Title: | Targeting the Sigma-2 Receptor (S2R) for Dry AMD with an Oral Small Molecule Approach: Preclinical & Clinical Biomarker Support | |
| Author: | Vice President of Research, Mary Hamby, Ph.D. |
About Dry Age-related Macular Degeneration
Dry AMD affects an estimated 10 million people in the U.S., 1.5 million of whom have advanced disease or geographic atrophy. Dry AMD is characterized by a progressive deterioration of the macula, a region of the retina comprised of photoreceptors, specialized neurons that convert light into electrical signals, and a layer of retinal pigment epithelial (RPE) cells, which forms the blood-retinal barrier and provides essential support functions to photoreceptors. Macular deterioration is believed to be caused by several factors, including oxidative stress, inflammation and the buildup of protein deposits called drusen, which form on the Bruch’s membrane below the RPE. A key function performed by RPE cells is the recycling of photoreceptor outer segments (POS). This process is impaired in dry AMD, resulting in the eventual loss of photoreceptors, which in turn leads to irreversible vision loss.
About Cognition Therapeutics
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/
Forward-Looking Statements
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Contact Information:
Cognition Therapeutics, Inc.
info@cogrx.com
Aline Sherwood (media)
Scienta Communications
asherwood@scientapr.com
Daniel Kontoh-Boateng / Rosalyn Christian (investors)
Tiberend Strategic Advisors, Inc.
dboateng@tiberend.com / rchristian@tiberend.com
FAQ
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