Genexine said on Wednesday that its novel anemia drug candidate, GX-E4 (ingredient: efepoetin alfa), confirmed non-inferiority to Roche’s Mircera (ingredient: methoxy polyethylene glycol-epoetin beta) in phase 3 clinical trials.
Genexine’s Indonesian partner, KGbio, presented the interim results of the study at the World Congress of Nephrology (WCN 2023) in Bangkok, Thailand, from March 30 to April 2.
The kidneys produce 90 percent of the erythropoietin (EPO) needed by the body but decreased kidney function causes renal anemia. GX-E4 is a long-acting EPO formulation that utilizes Genexine's proprietary long-acting hyFc fusion platform to dramatically extend the half-life of EPO in the body, the company said.
The trial, conducted in seven Asian and Oceanian countries, is an active-controlled, randomized, open-label study in 391 adult patients with stage 3 and 4 chronic kidney disease. The participants should have never received an erythropoiesis-stimulating agent (ESA) or have not received an ESA for at least 12 weeks before study entry.
The study objective aims to determine the non-inferiority of GX-E4 at 2-week and 4-week intervals compared to Roche's Mircera, a third-generation long-acting renal anemia drug.
Consequently, the interim results showed that GX-E4 dosed every two weeks resulted in a 69.6 percent response rate and 91.2 percent maintenance of hemoglobin levels, compared to 63.2 percent and 87.2 percent for Mircera respectively. Additionally, the change in hemoglobin level during the trial was 1.58 g/dL per month, which aligns with the Kidney Disease: Improving Global Outcome guideline of 1.0 to 2.0 g/dL per month.
The safety profile was also equivalent to Mircera.
"This trial demonstrates the global competitiveness of GX-E4 bodes well for the commercialization of our first product based on hyFc," said Genexine CEO Neil Warma. "Together with our partner KG Bio, we will continue to expand into non-dialysis as well as dialysis clinical trials to challenge the global market."
Genexine also added that they plan to complete the phase 3 trial of GX-E4 by the end of the year and begin the biologics license application (BLA) process, starting with Indonesia, followed by Korea and other Asian markets.