Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Tuesday the completion of first patient dosing in the Phase 2 clinical study of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, for the treatment of diabetic macular edema (DME).

This randomised, double-masked, multi-centre, active-controlled Phase 2 clinical study is intended to evaluate the efficacy and safety of intravitreal injections of efdamrofusp alfa in DME patients. A total of 150 participants will be enrolled and randomised 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. The primary endpoint is the change in best corrected visual acuity (BCVA) from baseline in the study eye at week 16.

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. To date, multiple clinical studies of efdamrofusp alfa have been conducted in patients with neovascular age-related macular degeneration (nAMD) and DME, among which high-dose (8 mg) efdamrofusp alfa has shown significant efficacy in improving visual acuity and retinal oedema. Meanwhile, efdamrofusp alfa has demonstrated the potential for extended dosing intervals (up to 12-16 weeks), with favourable safety and tolerability, Innovent said.