Pharma Focus Europe

Endogena Therapeutics Receives FDA Authorization for Innovative Treatment Targeting AMD

Wednesday, October 25, 2023

Endogena Therapeutics Inc., a pioneering biotechnology company dedicated to advancing regenerative medicine, is excited to announce a significant achievement with the potential to transform lives. The U.S. Food and Drug Administration (FDA) has granted clearance for Endogena's Investigational New Drug (IND) application, marking the beginning of a groundbreaking clinical investigation of EA-2351. This innovative compound offers hope to patients battling geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The eagerly awaited first-in-human study is set to commence in 2024.

This milestone represents the company's second program to advance into clinical trials, building on the momentum of its ongoing EA-2353 program for retinitis pigmentosa, which began in July 2022. EA-2351 and EA-2353 represent distinct approaches, each targeting specific cell populations through different pathways based on their unique chemical structures. While EA-2353 focuses on activating one set of cells in the context of retinitis pigmentosa, EA-2351 centers on retinal pigment epithelial (RPE) cells. These RPE cells play a pivotal role in regenerating and restoring photoreceptor function.

Endogena Therapeutics, expressed his enthusiasm for this momentous occasion, stating, "Our team is thrilled to have reached yet another significant milestone, and my thanks go to everyone involved. We look forward to continuing to develop yet another potential therapy for a condition with a high unmet medical need, thereby providing hope for patients affected by AMD."

"Many of us will know someone touched by this terrible disease, which makes our work even more pertinent. Our resilience, clear purpose, and the financial support from our shareholders have enabled us to reach this point and will help pave our way to future success."

Endogena Therapeutics remains dedicated to its mission of unlocking the body's regenerative potential and making a meaningful impact on patients' lives. This latest achievement reinforces the company's commitment to advancing innovative therapies for conditions that urgently require novel treatment options.

EA-2351 is a novel compound for the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). AMD is a leading cause of irreversible vision loss in the developed world, with nearly 9% of the population over 45 years of age estimated to be affected. The "dry" form of AMD is associated with atrophic cell death in the central retina or macula, accounting for 80-90% of the total AMD population.



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