Genexine's 'Epessa' Approved for Phase 3 Clinical Trial in Dialysis Patients in Korea

Genexine announced on the 23rd through a public disclosure that its long-acting novel anemia treatment 'Ephesa (GX-E4)' has received approval for a Phase 3 clinical trial application (IND) from the Korea Ministry of Food and Drug Safety for dialysis patients.

The new headquarters of Genexine, 'Genexine Progen Bio Innovation Park' (left building), located in Magok, Gangseo-gu, Seoul. On the right is the research institute of its affiliate Handok, 'Handok Future Complex.'
[Photo by Lee Chunhee]

Ephesa, developed based on Genexine's proprietary long-acting platform technology HybridFc (hyFc), is a treatment for chronic kidney disease (CKD) induced anemia caused by chronic kidney disease. Ephesa received marketing authorization from the Indonesian Food and Drug Authority (BPOM) on the 23rd of last month for non-dialysis patients and is preparing for its launch in Indonesia. Following this, it is preparing for marketing authorization in seven Asian countries including Korea.

Renal anemia refers to anemia caused by decreased production of erythropoietin (EPO) in the kidneys due to impaired kidney function. Renal anemia reduces the number of red blood cells, leading to insufficient oxygen supply and decreased energy production in organs, which lowers patient activity and causes fatigue, loss of appetite, reduced exercise capacity, insomnia or depression, thereby deteriorating quality of life and affecting patient mortality.

The ongoing Phase 3 clinical trial of Ephesa will be conducted in a total of 11 countries across Europe and Asia, including Korea, targeting long-acting renal anemia patients undergoing dialysis treatment. It aims to confirm efficacy and safety by testing non-inferiority against the active comparator 'Aranesp (darbepoetin alfa)' through randomized allocation and investigator-blinded methodology.

Hong Sung-joon, CEO of Genexine, stated, “We have already completed IND and ethics committee approval applications in 11 countries across Europe and Asia, and with the recent IND approval in Korea, we plan to rapidly obtain approvals overseas as well.” He added, “We will focus our capabilities on successfully completing this Phase 3 trial for dialysis patients to provide new treatment options for both non-dialysis and dialysis patients in the global market.”

This content was produced with the assistance of AI translation services.