Disc Medicine(US:IRON)2021-11-23 12:58GEM103 for Geographic Atrophy (GA) - Dry AMD affects approximately 16 million patients in the US, with about 90% (15 million) having dry AMD[6] - 80% (12 million) of dry AMD patients have variants in the CFH gene[6,9] - Gemini's GEM103 targets patients with genetically reduced Factor H function, aiming for precision medicine in AMD[4] - Phase 2a ReGAtta study enrolled patients with GA secondary to AMD, enriched for CFH genetic risk variants, with 85% having HH/HY variants[15] - Phase 2a data supports advancing a 500μg dose of GEM103 to late-stage development[16,20,29] GEM103 Safety and Biological Activity - GEM103 was generally well-tolerated in the ReGAtta study, with no increased risk for CNV in the GA population after over 500 injections[16,17] - 27.4% of patients experienced ocular AEs in the study eye, with one case of iritis related to GEM103, but no AEs led to discontinuation[17] - GEM103 demonstrated biological activity by reducing elevated complement biomarkers in GA patients, including a 43% reduction in Ba and a 37% reduction in C3a[16,22] Gemini's Pipeline and Financials - Gemini is also developing GEM307, a CFH potentiating antibody, with IND submission targeted for 1H 2022[7,33] - Gemini has a Phase 2a study of GEM103 as an adjunct to SOC in patients with neovascular AMD (nAMD)[30] - Gemini is capitalized to support milestones in 2021 and has a cash runway into 2023[32,33]