Gemini Therapeutics, Inc. announced updates from its ongoing phase 2a clinical studies of GEM103 and strategic evaluation of GEM103's clinical development program. GEM103 Phase 2a ReGAtta Study Update: Ongoing analysis of the 62 patients enrolled in the ReGAtta study continues to show that more than nine months of GEM103 exposure has been generally well-tolerated, able to durably reduce biomarkers of complement activation, and able to maintain supraphysiological levels of Complement Factor H (CFH). ReGAtta, an open-label, non-controlled study, was designed to evaluate GEM103's safety and pharmacokinetics (PK) over multiple intravitreal injections.

GEM103 Phase 2a as an Add-On to Anti-VEGF Therapy for the Treatment of Wet AMD Study Update: In December 2021, the Company received six-month data for the 50 patients enrolled in the wet AMD study. This study was designed to investigate the safety and tolerability of GEM103 as an adjunct to standard of care aflibercept therapy, with patients randomized 2:1 between a GEM103 plus aflibercept arm and a sham comparator plus aflibercept arm. Interim analysis showed that intravitreal GEM103 plus aflibercept was generally well-tolerated, and the safety profile was generally consistent with the sham plus aflibercept arm.

Patients in this study were dosed every other month concurrently with aflibercept. CFH levels remained supraphysiologic and greater than five times above baseline at the trough timepoints throughout the six months. GEM103 Study Plans: Having achieved the ReGAtta study's primary goal of assessing GEM103's safety and tolerability, as well as the primary goal of assessing GEM103's safety and tolerability as an add-on to aflibercept for the treatment of wet AMD, the Company will end both of these ongoing Phase 2a studies with patients returning for a final safety visit.