Early ReGAtta data of GEM103 show safety, tolerability in complement regulation
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Initial study data indicate GEM103 can regulate complement activity in geographic atrophy secondary to dry age-related macular degeneration and has a tolerable safety profile, according to a press release.
ReGAtta is an ongoing phase 2a multicenter, open-label, multiple ascending dose study evaluating the safety and tolerability of GEM103 (Gemini Therapeutics) in patients with geographic atrophy secondary to dry AMD.
As of May, patients receiving 250 µg or 500 µg intravitreal doses of GEM103 saw sustained, elevated complement factor H levels from the first evaluation point of 1 month, the release said. Levels continued to increase depending on the dose received. Biomarker changes show the therapy can “regulate the complement system and overall disease-related inflammation.” Patients experienced an approximately 40% decrease in Ba, an approximately 20% decrease in C3a and an increase in CFB across all genotypes.
The therapy has been well tolerated, with no serious adverse events related to the drug and no serious ocular adverse events. Sixteen patients experienced adverse events in the study eye, 12 of which were conjunctival hemorrhage related to the intravitreal injection. There was one case of choroidal neovascularization in a study eye in the 500 µg arm, but investigators determined it was not related to GEM103 or the injection procedure, the release said.
“This is an important milestone for the GEM103 program that supports the potential advantages of a well-tolerated safety profile without an increased risk for CNV and every other month dosing,” Jason Meyenburg, CEO of Gemini Therapeutics, said in the release.
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