Benzinga | Jul 22, 2021 04:18PM EDT

NGM Announces Completion Of Enrollment In Phase 2 CATALINA Study Of NGM621 In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration

NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced it has completed enrollment in the Phase 2 CATALINA study, which is evaluating the safety and efficacy of intravitreal (IVT) injections of NGM621 in patients with geographic atrophy secondary to age-related macular degeneration. Geographic atrophy is characterized by progressive retinal cell loss that results in irreversible loss of vision, and the disease affects approximately 1 million patients in the U.S. and 5 million patients globally. There are no approved treatments for geographic atrophy.

"Patients living with geographic atrophy, like those enrolled in CATALINA, may face significant and progressive vision loss that has far-reaching implications, including a loss of independence, depression and an increased risk of falls and fractures. Completing enrollment in CATALINA is an important milestone for NGM and the patients with geographic atrophy that we hope to serve. NGM621, as a monoclonal antibody with a high potency targeting C3 and the potential for every-eight-week dosing, may offer an innovative treatment option for this underserved patient population," said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM. "We are highly encouraged by the program's progress to date and for the potential of NGM621 to change the disease trajectory for geographic atrophy patients."

The Phase 2 CATALINA study enrolled a total of 320 patients with geographic atrophy, more than the originally planned 240 patients. Patients were enrolled and randomized to receive IVT injections of NGM621 or sham every four or eight weeks. The primary efficacy endpoint is the rate of change in geographic atrophy lesion area, as measured by fundus autofluorescence (FAF) imaging, over 52 weeks of treatment. NGM621 Phase 1 study results, which were first presented at the American Academy of Ophthalmology in November 2020, supported the advancement of the drug to the ongoing Phase 2 study.

"Building upon encouraging Phase 1 results demonstrating that NGM621 was well-tolerated and had an acceptable safety profile, the CATALINA study will provide additional safety information and will inform whether NGM621 may slow disease progression in patients with geographic atrophy," said Arshad M. Khanani, M.D., M.A., Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Associate Professor at the University of Nevada, Reno School of Medicine. "Complement inhibition continues to be a promising approach for the treatment of geographic atrophy, a disease that represents a major unmet need in ophthalmology, affecting millions of people around the world. As a retina specialist, it is extremely difficult to watch my geographic atrophy patients' disease worsen without being able to intervene effectively. I look forward to seeing top-line results from the CATALINA study next year, as we continue to strive for meaningful medical advancements for these patients."