Benzinga | Jul 27, 2020 08:08AM EDT

NGM Bio Announces Initiation Of Phase 2 CATALINA Study Of NGM621 In Patients With Geographic Atrophy (GA) Secondary To Age-Related Macular Degeneration

-- Multicenter, randomized, double-masked, sham-controlled study will evaluate safety and efficacy of

intravitreal injections of NGM621 every four or eight weeks for 48 weeks --

-- GA is a progressive, irreversible retinal degenerative disease with no approved therapies --

-- NGM621, a monoclonal antibody, is engineered to potently inhibit complement C3 with the

treatment goal of reducing disease progression in patients with GA --

SOUTH SAN FRANCISCO, Calif., July 27, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced it has initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial, to evaluate the safety and efficacy of intravitreal injections (IVT) of NGM621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA, an advanced form of AMD, is a progressive retinal degenerative disease associated with irreversible loss of vision, diminished quality of life and eventual blindness. Dysregulated activation of the complement system, a key component of the immune system, has been implicated in the onset and progression of GA. NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit activity of complement C3 with the treatment goal of reducing disease progression in patients with GA, and with the potential for every eight week dosing.

"The NGM621 program exemplifies our strategy to target powerful, disease-driving biology to deliver transformative medicines for patients across a range of therapeutic areas and diseases with high unmet need," Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio. "We are very encouraged by the preclinical data and Phase 1 safety and tolerability data for NGM621. Recognizing the severe, life-altering impact GA has on patients' lives, we are working to rapidly advance NGM621 through clinical development. We believe NGM621 offers a unique profile with best-in-class potential and could represent an important therapeutic advance for patients with GA."

NGM621 was discovered by NGM under its strategic collaboration with Merck. NGM successfully completed a first-in-human open-label Phase 1 study in which treatment with single- and multiple-dose IVT injections of NGM621 in patients with GA was well tolerated, supporting continued development. NGM plans to present the data from the Phase 1 study at an upcoming medical conference. NGM recently presented NGM621 preclinical findings at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held virtually in June 2020. The presentations are available on NGM's website here.

"As a retina specialist who manages patients with GA, I see first-hand the progressive and eventually devastating impact this disease can have on patients' quality of life. The insidious loss of vision leads to difficulty with everyday tasks and social isolation, in many cases robbing patients of their independence and ability to do things they enjoy. Often these patients live in fear of going blind, knowing that currently nothing can be done to slow their disease progression," said Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Houston and the Greater Houston Retina Research Foundation. "Complement inhibition continues to be a promising approach to slowing GA progression. I am pleased to see NGM621 move into a rigorous Phase 2 study and am encouraged by the data to date with this antibody that blocks C3 activation. I look forward to seeing how NGM621's C3 inhibition translates into clinical benefit."