China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302). This recombinant fully human anti-VEGF and anti-complement bispecific fusion protein aims to address unmet needs in nAMD treatment.
STAR Study Overview
The STAR study is a randomized, double-masked, active-controlled Phase III clinical trial designed to evaluate the efficacy and safety of intravitreal 8 mg IBI302 in subjects with nAMD. This study will support the potential new drug application for IBI302 (CTR20232229, ClinicalTrials.gov Identifier: NCT05972473). A total of 600 subjects will be enrolled and randomized into two arms: the 8 mg IBI302 group and the 2 mg aflibercept group, in a 1:1 ratio. Participants will undergo visits every 4 weeks throughout the study duration.
Subjects assigned to the IBI302 arm will receive 8 mg IBI302 intravitreal injections every 4 weeks up to Week 8, followed by personalized treatment intervals. Those in the aflibercept control arm will receive 2 mg aflibercept intravitreal injections every 4 weeks up to Week 8, transitioning to 2 mg aflibercept every 8 weeks thereafter. The primary endpoint focuses on changes from baseline in best corrected visual acuity (BCVA) letters in the study eye, assessed at Weeks 44, 48, and 52. All subjects will continue receiving intravitreal injections up to Week 96, concluding with a final study visit at Week 100.
IBI302: A First-in-Class Therapy
IBI302 is the first-in-class bispecific fusion protein that targets both VEGF and complement pathways, allowing for simultaneous inhibition of VEGF-mediated signaling and attenuation of inflammatory responses due to complement activation. Results from two Phase 2 clinical studies have shown favorable safety and efficacy profiles for IBI302 in nAMD patients, highlighting the benefits of long-interval dosing. Improvements in BCVA, retinal thickness, and neovascularization metrics have been observed, along with potential enhancements in macular atrophy and fibrosis. The overall safety profile remains favorable and comparable to existing anti-VEGF agents.-Fineline Info & Tech
