By Fineline Cube 
China-based Innovent Biologics, Inc. (HKG: 1801) announced the completion of the first patient dosing in the Phase II clinical study for efdamrofusp alfa (IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, in diabetic macular edema (DME).
Study Design
The randomized, double-masked, multi-center, active-controlled Phase II study is designed to assess the efficacy and safety of intravitreal injections of efdamrofusp alfa in DME patients. A total of 150 participants will be enrolled and randomized in a 1:1:1 ratio to the IBI302 4 mg group, the IBI302 8 mg group, and the Faricimab (anti-VEGF/ANG-2 bispecific antibody) 6 mg group.
Mechanism of Action
DME development is primarily driven by microvascular damage mediated by VEGF upregulation and inflammatory factors. Efdamrofusp alfa, the first-in-class bispecific fusion protein targeting VEGF and complement, can simultaneously inhibit angiogenesis and vascular leakage mediated by VEGF, and inflammatory responses mediated by complement activation. The drug previously demonstrated significant efficacy in studies in neovascular age-related macular degeneration (nAMD) and other indications.-Fineline Info & Tech