Anemia Treatment for Chronic Kidney Disease 'GX-E4'
Worma CEO "Commercialization Expected Within 1-2 Years"
Genexine announced on the 11th that 'GX-E4 (active ingredient epoetin alfa)', being developed as a treatment for anemia related to chronic kidney disease, demonstrated non-inferiority compared to Micera in a multinational Phase 3 clinical trial.
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]
Genexine is conducting a Phase 3 clinical trial of GX-E4 targeting non-dialysis chronic kidney disease patients in seven countries across Asia and Oceania, including South Korea and Indonesia, through KG Bio, a subsidiary of Kalbe Farma, the largest pharmaceutical company in Southeast Asia and Genexine’s partner in the Asian region. The kidneys produce 90% of erythropoietin (EPO), a hormone essential for red blood cell production in the body. Therefore, when kidney function declines, 'renal anemia' may occur. GX-E4 is a long-acting EPO formulation that utilizes Genexine’s proprietary long-acting protein therapeutic platform, hybrid Fc (hyFc) platform to extend the half-life of EPO in the body.
This Phase 3 trial is being conducted on 391 adult patients with stage 3 and 4 chronic kidney disease who have either never been treated with erythropoiesis-stimulating agents (ESA) or have not received ESA treatment for at least 12 weeks prior to enrollment. Through an active-controlled, randomized, open-label design, GX-E4 is administered at 2-week and 4-week (extended period) intervals and compared to Micera, a third-generation long-acting renal anemia treatment, to confirm non-inferiority.
According to interim results released by KG Bio, the response rate for GX-E4 administered every 2 weeks was 69.6%, and hemoglobin levels were maintained at 91.2%. During the same period, Micera showed a response rate of 63.2% and hemoglobin maintenance of 87.2%. Additionally, the change in hemoglobin levels during the evaluation period was 1.58 g/dL per month, which meets the Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommendation of 1.0 to 2.0 g/dL per month. Safety performance was also confirmed to be equivalent to Micera.
Genexine and KG Bio plan to complete the Phase 3 trial of GX-E4 soon and aim to receive top-line data by June. Previously, Neil Warma, CEO of Genexine, stated regarding GX-E4, "The biologics license application (BLA) process is already underway in Indonesia," and added, "Commercialization through KG Bio is expected within 1 to 2 years." This is why GX-E4 is highly anticipated as Genexine’s first commercialized drug after 24 years since its founding. The plan is to sequentially proceed with the BLA process starting in Indonesia and expand into the South Korean and Asian markets.
Especially as the EPO market continues to grow steadily, with the share of long-acting EPO expected to reach 63% by 2028, it is anticipated that even capturing a 10% market share in Asia and Europe could generate sales of approximately $130 million (about 171.6 billion KRW).
CEO Warma said, "This clinical trial once again demonstrated the global competitiveness of GX-E4 developed using Genexine’s proprietary hyFc platform, which allows us to highly anticipate the commercialization potential of the first product developed based on hyFc. Moving forward, together with our partner KG Bio, we will expand clinical trials not only for non-dialysis patients but also for dialysis patients and challenge the global market." In addition to GX-E4, Genexine is conducting a Phase 3 clinical trial of 'GX-H9', a long-acting growth hormone developed using the hyFc platform, and 'GX-I7', a treatment for lymphopenia, is in Phase 2 clinical trials.
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