Gemini Therapeutics Completes Enrollment in Phase 2a Study of GEM103 as an Add-On to Anti-VEGF Therapy for the Treatment of Wet AMD
Gemini Therapeutics 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.
“Both physicians and patients recognize the limitations of anti-VEGF treatment, with approximately a third of patients developing reduced visual acuity and MA over time,” Samuel Barone, MD, Chief Medical Officer of Gemini Therapeutics, said in a company news release. “The team’s ability to over-enroll the study highlights the unmet need and the potential for GEM103 to address these suboptimal outcomes in the setting of regular anti-VEGF therapy and its subsequent depletion in CFH levels causing complement dysfunction.”
“Achieving our enrollment completion target for this trial is another milestone in our GEM103 program’s progress, and we anticipate additional data in 2021 to provide critical information on GEM103’s safety, pharmacokinietcs and biological activity in patients with either dry AMD or those receiving anti-VEGF treatment for wet AMD,” Jason Meyenburg, Chief Executive Officer of Gemini Therapeutics, said in the news release. “We look forward to releasing data from this study in patients with wet AMD before year end as we continue to evaluate CFH’s role as the primary endogenous complement regulator and it’s ability to restore retinal homeostasis in AMD.”
About the Phase 2a Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
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 12 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.
About GEM103
Gemini’s lead program, GEM103, a full-length recombinant complement factor H (rCFH) protein, is believed to be the first ever recombinant native complement regulator. GEM103 delivered by intravitreal injection is designed to address both complement hyperactivity and restore retinal health in patients with AMD. In a genetically-defined subset of AMD patients, GEM103 may circumvent dysfunctional CFH loss-of-function variants and slow the progression of their retinal disease. In patients undergoing anti-VEGF treatment, GEM103 may help regulate the hyperactive amplification of the alternative pathway believed to lead to cell loss and macular atrophy. The FDA granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.