Endogena Therapeutics Secures FDA Green Light to Initiate Trials for Geographic Atrophy Treatment

Endogena Therapeutics announced that the FDA has granted clearance for Endogena's investigational new drug (IND) application, allowing the company to commence a first-in-human study in 2024 for its geographic atrophy drug cadidate EA 2351.

This milestone marks the company's second program to progress into clinical trials, following its EA 2353 program for retinitis pigmentosa initiated in July 2022. EA-2351 and EA-2353 represent distinct approaches, each targeting specific cell populations through different pathways. 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, according to Endogena.

"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," Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics, said in a company news release. “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."