FDA grants Endogena’s Investigational New Drug application for EA 2351

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The US Food and Drug Administration (FDA) has granted clearance for Endogena's Investigational New Drug (IND) application for clinical investigation of EA 2351. This compound will be evaluated for the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The company shared in their press release that the first-in-human study is set to commence in 2024.¹

With this clearance, Endogena marks their second program to progress into clinical trials, with its ongoing EA 2353 program for retinitis pigmentosa, initiated in July 2022 being the first. Both EA-2351 and EA-2353 target specific cell populations but through different pathways, due to their unique chemical structures. EA-2353 focuses on activating one set of cells in the context of retinitis pigmentosa. EA-2351 centers on retinal pigment epithelial (RPE) cells.¹

In the press release¹, Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics, shared his excitement for the company’s milestone and his hope for the future of this compound, saying, "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."

Reference:

1. Endogena Therapeutics Secures FDA Green Light for Breakthrough AMD Treatment. Endogena Therapeutics Inc. October 24, 2023. Accessed October 24, 2023. https://www.globenewswire.com/news-release/2023/10/24/2765328/0/en/Endogena-Therapeutics-Secures-FDA-Green-Light-for-Breakthrough-AMD-Treatment.html