Oral Zervimesine Reduces Geographic Atrophy Lesion Growth in Phase 2 Trial

Oral zervimesine (CT1812) successfully reduced lesion growth in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in topline results from the Phase 2 MAGNIFY trial, as announced on May 8, 2025, by Cognition Therapeutics.1

Zervimesine, an oral, once-daily pill, is under development for the treatment of diseases like Alzheimer’s and dementia with Lewy bodies (DLB). Both diseases are associated with the buildup of certain proteins in the brain, which bind to and eventually destroy neurons. They often result in a progressive loss of the ability to learn, recall memories, and communicate, and frequently result in death.1

“These results in dry AMD represent yet another indication in which zervimesine has potential to slow the progression of disease with a once-daily oral pill,” said Anthony O. Caggiano, MD, PhD, chief medical officer and head of R&D at Cognition Therapeutics. “Compared to current treatment options, which require regular clinic visits for intravitreal injections, an effective oral treatment that patients can take at home would be truly transformative.”1

GA is an advanced form of AMD that eventually leads to irreversible vision loss. It is marked by the presence of sharply demarcated lesions on the outer retina, which are caused by the loss of photoreceptors, retinal pigment epithelium, and underlying choriocapillaris. Dry AMD is the more prevalent of the two existing forms of AMD, accounting for up to 90% of all cases.1,2

MAGNIFY was a double-masked, placebo-controlled Phase 2 clinical trial, initially planning to enroll 246 adults with GA secondary to dry AMD. However, the study was concluded after roughly 100 participants were enrolled. These participants were randomized to receive 200 mg of once-daily oral zervimesine or placebo; they were then assessed for safety and tolerability, changes in GA lesion size and growth rate, changes in visual acuity, and other anatomic and visual measures.1

Investigators measured the change in GA lesions through growth rate and size. A slope analysis in MAGNIFY found the trajectory of GA slowed by approximately 28.6% in participants treated with zervimesine.

Further analysis showed those treated with zervimesine had a reduction in GA lesion growth rate of 12% at 6 months, 16% at 12 months, and 28.2% by the termination of the trial at 18 months, compared with placebo. Cognition Therapeutics indicated that nearly two-thirds of patients completed 12 months and one-third completed 18 months of dosing.1

The company also announced safety, demographic, and visual and anatomic outcomes will be reported later, as they are still undergoing analysis. However, zervimesine has been well tolerated in clinical studies for Alzheimer’s and DLB to date.1

“Dry AMD is now the third indication in which we have shown efficacy signals with a once-daily oral drug,” said Lisa Ricciardi, Cognition Therapeutics’ president and chief executive officer. “We believe zervimesine has the potential to be used as a monotherapy or in combination with existing medications. This would allow physicians the flexibility to tailor treatment regimens for their patients.”1

References

1. Cognition Therapeutics, Inc. Cognition Therapeutics Reports Topline Results Showing Oral Zervimesine (CT1812) Reduced Lesion Growth in Phase 2 Study in Geographic Atrophy. GlobeNewswire. 8 May 2025. Accessed 8 May 2025. https://www.globenewswire.com/news-release/2025/05/08/3077141/0/en/Cognition-Therapeutics-Reports-Topline-Results-Showing-Oral-Zervimesine-CT1812-Reduced-Lesion-Growth-in-Phase-2-Study-in-Geographic-Atrophy.html

2. Fleckenstein M, Mitchell P, Freund KB, et al. The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmology. 2018;125(3):369-390. doi:10.1016/j.ophtha.2017.08.038