GX-E4(Efepoetin alfa)

A recombinant human erythropoietin(EPO) fused to hyFc

Disease Indication

CKD induced Anemia(Dialysis and nondialysis)

Development Stage

Clinical Development(Phase 3)
(Commercial stage after completing Phase 3 in Asia, bridging clinical trials ongoing in Europe)

Safety and tolerability were evaluated from phase 1 clinical trial in healthy volunteers, and phase 2 clinical trial in anemia patients with CKD have been completed and is currently in phase 3 trial with patients in 7 countries in Asia and Oceania.

1. 1 Study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of GX-E2 in healthy subjects. NCT02291991(Phase I, Completed)
2. 2 Study to evaluate the efficacy and safety of GX-E2 in anemic patients diagnosed With chronic kidney disease(CKD). NCT02044653(Phase II, Completed)
3. 3 A study of Efepoetin alfa in treating anaemia associated with chronic kidney diseases patient. NCT04155125

Summary

GX-E4 is a Long-acting Erythropoiesis simulating agent. Differing from marketed glycosylation or PEGylation products, it uses the hyFc fusion protein technology to maximize half-life of the efficacy. It is intended for the treatment and for maintenance of anemia induced by chronic kidney disease(CKD) with or without dialysis.

Structure

It has non-cytolytic properties because it uses a sequence that does not have the ability to induce cytotoxicity among the sites of IgG4 and IgD that exist in vivo.

Mechanism

GX-E4 promotes erythropoiesis by interacting with erythropoietin receptors on the red blood cell (RBC) surface, resulting in the proliferation and terminal differentiation of erythroid progenitor cells.

크게보기

Advantages

1. 1Cost effective
2. 2Less dosing frequency & longer half-life compared to Epoetin alfa/beta
3. 3Non-inferior efficacy & excellent safety profile compared to Aranesp/Mircera
4. 4Slow & less fluctuation of Hb levels

Publication

Presentation at 2017 ASN Poster, Presentation at The Korean Society of Nephrology in 2018