Gemini Therapeutics has commenced a Phase IIa trial of GEM103 for patients with wet age-related macular degeneration (AMD) who have or may be at risk of macular atrophy (MA).
The trial will advance GEM103 as a potential add-on therapy to anti-vascular endothelial growth factor (anti-VEGF) treatment.
A recombinant human complement factor H (CFH) protein, GEM103 can potentially address both complement hyperactivity as well as restore retinal health in AMD patients.
Estimates show that of the 15 million dry AMD patients, about 40% have variants in the CFH gene. Such loss-of-function variants are linked to increased risk of dry AMD disease.
Gemini Therapeutics chief medical officer Marc Uknis said: “Current anti-VEGF therapies have improved the quality of life for patients with wet AMD.
“However, there is no therapy for the MA that can develop in some patients. In these patients, ongoing anti-VEGF therapy has been associated with a compartmental insufficiency of CFH activity.
“In this setting, GEM103, a recombinant human CFH, has the potential to be a meaningful add-on therapy.”
The randomised, single-masked and sham-controlled study of patients needing ongoing VEGF inhibition for wet AMD will analyse safety, tolerability, the effect of GEM103 on CFH levels and disease-relevant biomarkers in the ocular compartment.
The company anticipates topline data from the trial in the second half of this year.
Gemini Therapeutics CEO Jason Meyenburg said: “The addition of a clinical research programme targeting a selected wet AMD population is a natural next step for Gemini and builds on our existing focus in genetically-defined dry AMD.
“This study is an important next phase in our understanding of the potential role of GEM103 as an add-on therapy in a subset of patients with wet AMD who go on to have co-morbid macular atrophy.”
Last month, Gemini Therapeutics commenced patient enrolment in its Phase I study of GEM103 for the treatment of dry age-related macular degeneration (AMD).