CAMBRIDGE, Mass.--(BUSINESS WIRE)--Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that GEM103, the Company’s investigational treatment for dry AMD, has been granted Fast Track designation by the United States Food and Drug Administration (FDA). Gemini is evaluating GEM103, a recombinant, human complement factor H (CFH), for its ability to address the multiple AMD pathobiologies in genetically-defined subsets of AMD patients caused by CFH loss-of-function variants and slow the progression of their disease. CFH loss-of-function variants are present in approximately 40% of patients with AMD. The ongoing Phase 2a ReGAtta study is evaluating GEM103 in patients with geographic atrophy (GA) secondary to dry AMD.
“We are pleased that the FDA has granted Fast Track designation to GEM103, which has the potential to be an important therapeutic option for patients with dry AMD and CFH loss-of- function gene variants,” said Jason Meyenburg, CEO of Gemini Therapeutics. “The FDA’s recognition of the existing unmet need in this patient population and this decision underscores the potential of GEM103 and its unique mechanism of action to treat this large population of AMD patients.”
Fast Track is an FDA designation intended to facilitate development and expedite review of investigational therapies to address unmet medical needs in the treatment of conditions for which non-clinical or clinical data has demonstrated the potential of the therapy to address this medical need. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for Accelerated Approval and Priority Review, and a Rolling Review, in which Gemini has the opportunity to submit completed sections of a Biologics Licensing Application (BLA) for review by the FDA, rather than waiting to complete the regulatory submission before it can be submitted for review.
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, 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 native complement modulator, full-length recombinant complement factor H (rCFH) protein. When delivered by intravitreal injection, GEM103 has the potential to address unmet medical need in genetically-defined subsets of AMD patients by circumventing dysfunctional CFH loss-of-function variants and slowing the progression of their retinal disease.
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 modulator, 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 the 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. The company has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies.
For more information, visit www.geminitherapeutics.com.
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