Endogena Therapeutics Secures FDA Green Light for Breakthrough AMD Treatment

Endogena Therapeutics Secures FDA Green Light for Breakthrough AMD Treatment

San Francisco, USA; Toronto, Canada; Zürich, Switzerland, October 24, 2023

Endogena Therapeutics Inc., a pioneering biotech company dedicated to revolutionizing regenerative medicine, is proud to announce a significant achievement that holds the promise of transforming lives. The U.S. Food and Drug Administration (FDA) has granted clearance for Endogena's Investigational New Drug (IND) application, opening the door to 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 marks the company's second program to progress into clinical trials, building on the momentum of its ongoing 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, hinging 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.

Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics, expressed his enthusiasm for this momentous occasion: "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.

-ENDS-

See our YouTube channel for a video explaining how EA-2351 works.

About EA-2351

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, and it has been estimated that almost 9% of the population older than 45 years of age are affected. The “dry” form of AMD is associated with atrophic cell death of the central retina or macula, and it accounts for 80-90% of the total AMD population. 

About Endogena

Endogena Therapeutics Inc. is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Its approach has the potential to change the way degenerative conditions related to aging and genetic disorders are treated. The concept is based on the selective regulation of endogenous adult stem- and progenitor cells for controlled tissue repair by small molecules. Endogena’s most advanced programs target degenerative diseases of the eye, including retinitis pigmentosa and geographic atrophy (secondary to age-related macular degeneration). Endogena is registered in San Francisco, USA, with a head office in Zürich, Switzerland, and a research facility at JLABS in Toronto, Canada.

See our YouTube channel for a video explaining how endogenous regenerative medicine works.

For more information, please visit www.endogena.com

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