Cognition Therapeutics has announced plans to commence the Phase II MAGNIFY clinical trial of its oral drug candidate, CT1812, for dry age-related macular degeneration (dry AMD) this year.
The company’s decision comes after its investigational new drug (IND) application to study CT1812 for geographic atrophy (GA) secondary to dry AMD received clearance from the US Food and Drug Administration (FDA).
The randomised, placebo-controlled Phase II MAGNIFY trial (COG2201) is expected to enrol nearly 246 people diagnosed with dry AMD with measurable GA.
Cognition Therapeutics chief medical officer and head of research and development Anthony Caggiano said: “We enjoyed a collaborative dialogue with the ophthalmology division of the FDA during our pre-IND meeting and are excited to assess the potential of CT1812 to impact GA and slow the decline in visual acuity in people with dry AMD.
“We believe that CT1812’s oral systemic delivery, combined with its potential to protect the retinal pigment epithelium (RPE) from damage in both the affected and fellow eyes, may represent a significant advantage to the millions of people with dry AMD who are at risk for permanent vision loss.”
Change in GA lesion size and best-corrected visual acuity, along with other safety and efficacy measures, will be evaluated over the treatment period for determining if the treatment can slow vision loss.
Cognition Therapeutics president and CEO Lisa Ricciardi said: “Expansion of our pipeline programs into GA is an excellent example of how we are leveraging our scientific expertise to tackle some of the most challenging diseases.”
The experimental, orally delivered small molecule CT1812 is designed to penetrate the blood-brain and blood-retina barriers and selectively attach to the sigma-2 (σ-2) receptor complex.