Gemini Therapeutics Announces Data from Its Ongoing Phase 2a Study of GEM103 at EURETINA 2021

Gemini Therapeutics announced that Raj Maturi, MD, Adjunct Clinical Assistant Professor of Ophthalmology at Indiana University School of Medicine and an investigator in the ReGAtta study, presented Gemini’s previously released initial results from its ongoing phase 2a study at EURETINA 2021 Virtual, which was held September 9-12, 2021. The ReGAtta study is an open-label, single-arm dose escalation study of GEM103 in genetically-defined patients with geographic atrophy (GA) secondary to dry AMD.

“The initial results presented at EURETINA 2021 highlight the potential of GEM103 as a new treatment method for AMD and add to the understanding of its safety profile, mechanism of action, and duration, all of which will inform late-stage trial design,” Samuel Barone, MD, Chief Medical Officer at Gemini, said in a company news release. “Results thus far demonstrate that GEM103 continues to be well-tolerated. In addition, GEM103’s ability to regulate complement is evidenced through a rapid and sustained reduction of biomarkers elevated in AMD and pharmacokinetics support bi-monthly intravitreal dosing.”

Summarized observations from the ongoing phase 2a ReGAtta study, as of May 2021, presented at EURETINA 2021 include the following:

• For the 62 patients with GA enrolled, no systemic serious adverse events related to GEM103 were observed as of the May 2021 snapshot. Ocular adverse events observed were related to the intravitreal procedure and are commonly associated with IVT procedure. Ocular inflammation was rare, mild and did not result in interruption of GEM103 administration. No choroidal neovascularization (CNV) was detected via retinal imaging.
• Repeat dosing with GEM103 resulted in rapid and sustained increased levels of complement factor H (CFH) in aqueous humor and supports the evaluation of every other month dosing in late-stage development studies.
• GEM103 demonstrated the ability to regulate complement in patients with GA, with treatment resulting in a reduction of elevated complement biomarkers and a dose dependent reduction in overall inflammatory state converging at 90 days. Timing of biomarker reductions was consistent with the accumulation of CHF with repeat dosing.

Information on Gemini Therapeutics, including GEM103 and initial ReGAtta data, and presentations made at EURETINA 2021 Virtual are available on Gemini Therapeutics’ website under the Investors & Media section: Events and Presentations.

About the Phase 2a ReGAtta Study

The ongoing phase 2a, multicenter, open-label, multiple ascending dose study of GEM103 in genetically-defined patients with GA secondary to dry AMD is designed to investigate safety and tolerability, PK, exploratory ocular biomarkers, and measures of retinal anatomy and function and not assess efficacy of GEM103 in GA. GEM103 is delivered monthly by an intravitreal injection and PK and biomarkers of complement regulation are determined from aqueous humor sampling. To date, the study has enrolled 62 patients with gene variants that have been linked to the progression of dry AMD from early to late-stage. The study’s design allowed for imbalances in GA baseline characteristics and does not inform GA efficacy and does not allow comparisons with uncontrolled fellow eye with similar imbalances.