September 10, 2020
Gemini Therapeutics enrolls first patients for its phase 2a ReGAtta study to evaluate the safety and efficacy of GEM-103 for the treatment of patients with GA secondary to dry AMD. The study will recruit up to 80 participants and will include both patients from the phase 1 study as well as treatment-naïve patients. Participants will be administered with IVT injections of GEM-103 dosed either monthly or every other monthly.
The phase 1 SAD study assessing the PK and tolerability of GEM-103 has completed enrollment and topline results indicated that the study has met all of its endpoints. Four ascending doses administered in 12 patients demonstrated no dose limiting toxicities, no inflammation, no anti-drug antibody, and no treatment-related adverse events. IVT injection of GEM-103 also resulted in prolonged supraphysiologic CFH that had an affect on biomarkers of complement hyperactivity as measured by aqueous humor taps.