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.

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“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).