Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that Raj Maturi, M.D., 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 held from 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,” said Samuel Barone, M.D., Chief Medical Officer at Gemini. “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, multi-center, 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.
Gemini’s lead program, GEM103, is a pioneering precision medicine approach, targeting trial enrichment with genetically defined patients. GEM103 targets a genetically defined subset of age-related macular degeneration (AMD) patients with complement dysregulation. Of the 15 million dry AMD patients in the United States, approximately 40% (or six million) have variants in the complement factor H (CFH) gene. Such loss of function variants are associated with increased dry AMD disease risk. GEM103 is believed to be the first ever recombinant complement regulator and is a full-length and human, recombinant complement factor H (rCFH) protein. When delivered by intravitreal injection, we believe GEM103 has the potential to address unmet medical need in genetically defined AMD patients by circumventing the complement dysfunction resulting from CFH loss of function variants and slowing the progression of their retina disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.
About Dry Age-Related Macular Degeneration (AMD)
Age-related macular degeneration (AMD) is a progressive retinal disease affecting millions of older adults, and the leading cause of irreversible blindness in the western world. Symptoms, which include blurry vision, loss of night vision and loss of central vision, make activities of daily living such as reading, driving and even recognizing faces progressively more difficult. Third-party reports indicate there are approximately 16 million patients with AMD in the United States alone. Dry AMD, which results from an interaction of environmental and genetic risk factors, represents about 90% of that population (or about 15 million) in the US compared to about 1.4 million with wet AMD. Genetic risk of developing dry AMD is significant, with approximately 70% attributable risk of advanced disease to heritability, while aging and smoking confer the strongest non-genetic risk. CFH risk variants occur in approximately 40% of patients with dry AMD and these patients have a significantly increased risk of developing the disease as well as progression from intermediate AMD to GA. The complement system, of which CFH is a regulator, is dysregulated in patients with these risk variants, and results in amplification of aberrant inflammatory responses in the eye. Over time, this dysregulation leads to damage to the macular region of the retina.
About Gemini Therapeutics
Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini’s lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. Gemini has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.
For more information, visit www.geminitherapeutics.com.
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Joshua R. Mansbach