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Cognition Therapeutics’ IND for geographic atrophy earns FDA OK

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The FDA has cleared Cognition Therapeutics’ investigational new drug (IND) application for CT1812, its lead candidate for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Tell me about CT1812.

CT1812 is an experimental, first-in-class, small molecule currently being investigated for five indications, including dry AMD, and three ongoing phase 2 trials for early and mild-to-moderate Alzheimer’s disease and dementia.

The orally-administered drug is designed to penetrate the blood-brain and blood–retina barriers as well as selectively bind to the sigma-2 (σ-2) receptor complex, which is involved in regulating key cellular processes.

How does this help dry AMD?

In dry AMD, when neurons and retinal pigment epithelium (RPE) cells in the central nervous system are damaged, this can lead to a loss of visual acuity and, later, vision as a whole.

According to Cognition, previous proof-of-concept studies have found that σ-2 receptor modulators rescue retinal pigment epithelium (RPE) cells from stressor-caused damage and, as a result, preserve the macula.

Any upcoming trials?

Yes! Cognition is planning to initiate a phase 2 MAGNIFY study (COG2201) as a randomized, placebo-controlled trial with an estimated 246 participants diagnosed with dry AMD with measurable GA.

What will be studied?

Safety and efficacy measures such as changes in GA lesion size and best-corrected visual acuity (BCVA) will be among the factors assessed in order to evaluate CT1812’s effectiveness in slowing vision loss.

When is the trial expected to commence?

The company plans to initiate enrollment for the MAGNIFY study later this year.