CAMBRIDGE, Mass.–(BUSINESS WIRE)–Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically-defined age-related macular degeneration (AMD), today 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,” said Samuel Barone, M.D., Chief Medical Officer of Gemini Therapeutics. “The team’s ability to overenroll 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,” said Jason Meyenburg, Chief Executive Officer of Gemini Therapeutics. “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 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.
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 U.S. Food and Drug Administration (FDA) granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.
About Wet Age-Related Macular Degeneration (AMD)
Age-related macular degeneration (AMD) is a progressive retinal disease affecting millions of older adults, and the leading cause of irreversible blindness in the western world. Symptoms, which include blurry vision, loss of night vision and loss of central vision, make activities of daily living such as reading, driving and even recognizing faces progressively more difficult. Third-party reports indicate there are approximately 16 million patients with AMD in the United States alone. Wet AMD is the most severe form characterized by neovascularization of the retina, leading to significant loss in visual acuity and rapid progression to blindness. There are approximately 1.4 million patients with wet AMD in the United States and over 2.5 million patients in the European Union. Wet AMD is most common in individuals over the age of 50, with increasing incidence every decade thereafter. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. However, there is still no approved therapy for patients with wet AMD who have or may be at risk for vision loss from macular atrophy associated with ongoing need for anti-VEGF treatment.
About Gemini Therapeutics
Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini’s lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. The Company has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.
For more information, visit www.geminitherapeutics.com.
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