Cognition Therapeutics Inc. (NASDAQ: CGTX) has received a green light from the U.S. Food and Drug Administration (FDA) to move forward with their Investigational New Drug (IND) application for CT1812, a potential treatment for geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The company plans to launch the Phase 2 MAGNIFY trial of the oral drug candidate CT1812 in 2023, bringing hope to individuals with dry AMD who have measurable GA.
Cognition’s Chief Medical Officer and Head of R&D, Anthony Caggiano, M.D., Ph.D., expressed his excitement after a successful pre-IND meeting with the ophthalmology division of the FDA. He is enthusiastic to assess the potential of CT1812 to impact GA and slow the decline in visual acuity in people with dry AMD. With its potential to protect the retinal pigment epithelium (RPE) from damage in both the affected and fellow eyes, CT1812’s oral systemic delivery may provide a significant benefit to the millions of people with dry AMD who are at risk for permanent vision loss.
The MAGNIFY study (COG2201) is a groundbreaking clinical trial that offers new hope for people diagnosed with dry age-related macular degeneration (AMD). In this randomized, placebo-controlled phase 2 trial, 246 participants will have the opportunity to be part of a revolutionary investigation into whether treatment can slow vision loss caused by AMD. Outcomes of the trial will be measured by changes in GA lesion size, best-corrected visual acuity, and other important safety and efficacy indicators.
Cognition is continuing to make strides in its fight against challenging diseases with the expansion of its pipeline programs into Georgia. Lisa Ricciardi, president and CEO of Cognition, is thrilled with their progress, especially as they move their CT1812 drug into a new indication. With their scientific expertise, they are one step closer to making a difference in those suffering from these diseases.
CT1812 is an exciting new small molecule that has the potential to revolutionize the treatment of dry AMD. It is designed to penetrate the blood-brain and blood-retina barriers, binding selectively to the sigma-2 (σ-2) receptor complex which plays an important role in the regulation of key cellular processes. By targeting the receptor complex, CT1812 could reduce the damage caused by toxic interaction with soluble beta amyloid (Aβ) oligomers, oxidative stress and other stressors in sensitive cells such as neurons and RPE cells. By protecting these cells from harm, CT1812 may help to prevent the gradual vision loss associated with dry AMD, potentially restoring vision and improving the quality of life for those affected.
Early evidence suggests that CT1812, a σ-2 receptor modulator, may be capable of protecting sensitive retinal pigment epithelium (RPE) cells from damage caused by pathogenic proteins and oxidative stress. If successful, this protective effect could preserve the integrity of the macula, a vital part of the eye responsible for sharp vision.
Cognitions is excited to announce the launch of their Phase 2 MAGNIFY clinical trial, studying the potential of CT1812 for treating mild-to-moderate Alzheimer’s disease. In addition, CT1812 is being studied in three ongoing Phase 2 clinical trials: the SEQUEL study, the SHINE study, and the SHIMMER study. The results of these trials could potentially lead to the approval of CT1812 by the U.S. FDA and other regulatory agencies.
About Geographic Atrophy Secondary to Dry AMD
Dry AMD, a degenerative condition affecting the macula of the retina, is an unfortunate reality for millions of people over the age of 50 worldwide, with one million of those cases in the United States alone. This form of AMD can cause gradual loss of central vision, making tasks like reading and driving more difficult. In its worst stages, Dry AMD can develop into geographic atrophy, leading to permanent vision loss. Thankfully, there are treatments available to help slow the progression of this condition.
About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc. is a pioneering biopharmaceutical company dedicated to the development of groundbreaking small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina. Our lead candidate, CT1812, is being investigated in clinical programs for Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). By targeting the σ-2 receptor with CT1812, we are using a revolutionary approach to address the pathways impaired in these diseases. Our research and development efforts offer a new hope in treating degenerative diseases.