NGM Bio Presents Phase 1 Safety and Pharmacokinetics Data for NGM621, an Anti-Complement C3 Antibody, in Patients with Geographic Atrophy at the American Academy of Ophthalmology 2020 Virtual
--Single and multiple intravitreal injections of NGM621 appeared safe and well tolerated in first-in-human study, with no patients experiencing serious adverse events, drug-related AEs, intraocular inflammation or choroidal neovascularization--
--The serum pharmacokinetics (PK) of NGM621 were linear and dose-proportional--
--NGM621 ocular PK/pharmacodynamics (PD) modeling supports potential for up to every eight-week dosing regimen--
--Enrollment of the CATALINA Phase 2 study of NGM621 in patients with geographic atrophy underway with the first patient dosed in July 2020--
SOUTH SAN FRANCISCO, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, announced that findings from its Phase 1 clinical study of NGM621, an anti-complement C3 antibody, in patients with geographic atrophy (GA) were presented today at the American Academy of Ophthalmology 2020 Virtual. The poster presentation titled, “Inhibition of Complement Component 3 in GA With NGM621: Phase 1 Dose-Escalation Study Results,” was given by the study’s lead investigator Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Houston and the Greater Houston Retina Research Foundation. The presentation is available on the NGM Bio website here.
The primary objective of the Phase 1 trial was to assess the safety and tolerability of single and multiple intravitreal (IVT) injections of NGM621 in patients with GA. Secondary objectives were to characterize the serum PK of single or multiple doses of NGM621. The study enrolled 15 patients across three single-ascending dose cohorts of NGM621, 2 mg, 7.5 mg and 15 mg, the maximum planned dose in the study, and a multiple dose cohort that received two 15 mg doses separated by four weeks. Patients were dosed sequentially and followed closely over 12 weeks.
In the study, NGM621 was well tolerated, with no patients experiencing serious adverse events (SAEs), drug-related adverse events (AEs), intraocular inflammation, endophthalmitis or choroidal neovascularization (CNV). No dose-related safety patterns or concerns were reported. Ocular AEs observed were mild in severity and representative of those commonly associated with IVT injections. No vision-related safety signals were detected. On average, patients maintained their visual acuity over the 12-week follow-up study duration.