Gemini Therapeutics Completes Enrollment in Phase 2a Study of Gem103 as an Add-On to anti-VEGF Therapy for the Treatment of Wet Amd Patients at Risk for Progressive Vision Loss Due to Macular Atrophy
May 13, 2021 at 04:30 pm IST
Gemini Therapeutics, Inc. announced the completion of enrollment in its Phase 2a trial advancing GEM103 as a potential add-on therapy for patients suffering from wet AMD and requiring continued anti-vascular endothelial growth factor (anti-VEGF) treatment who have, or may be at risk for, macular atrophy (MA). Topline data related to safety, tolerability, effect on intraocular complement factor H (CFH) levels and disease-relevant biomarkers of complement regulation is expected in late 2021. The ongoing Phase 2a, multicenter, multiple-dose study in subjects with Neovascular Age-related Macular
Degeneration (nAMD) with or at risk for macular atrophy, is designed to investigate the safety and tolerability
of GEM103 as an adjunct to standard of care aflibercept therapy. The study is designed to enroll approximately
45 patients randomized 2:1 between GEM103 plus aflibercept and sham plus aflibercept arms, with treatment
administered via intravitreal injection every other month for twelve months. CFH levels and disease relevant
biomarkers of complement regulation are determined from aqueous humor sampling throughout the study with visual
acuity and macular atrophy size measured at defined dosing dates.