Innovent Biologics, Inc. (HKG: 1801), a China-based biopharmaceutical company, has published the latest clinical results for its two drug candidates, efdamrofusp alfa (IBI302) and IBI324, at the American Association of Ophthalmology (AAO) meeting. IBI302 is a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein, while IBI324 is a bispecific antibody targeting vascular endothelial growth factor A (VEGF-A) and angiopoietin2 (Ang-2).
Phase II Clinical Study for IBI302 in Neovascular Age-Related Macular Degeneration (nAMD)
The Phase II clinical study for IBI302 enrolled 231 subjects with nAMD, who were randomly treated with 2 mg IBI302, 4 mg IBI302, or 2 mg aflibercept at a ratio of 1:1:1. The results demonstrated that the best corrected visual acuity (BCVA) in the 2 mg/4 mg IBI302 group at 36 weeks was not inferior to the baseline change in the aflibercept group. Additionally, the improvement in central subfield thickness (CST) measured by optical coherence tomography (OCT) was comparable between groups. Preliminary signals indicated a potential for the prevention of macular atrophy and fibrosis with IBI302, and the safety profile was favorable, with no occurrences of endophthalmitis or retinal vasculitis.
Conclusion and Implications
The positive outcomes from the Phase II clinical study of IBI302 and the data on IBI324 highlight Innovent Biologics’ commitment to advancing novel treatments in ophthalmology. These results not only underscore the potential efficacy of the company’s drug candidates but also their safety, which is crucial for patient care and treatment outcomes in the field of eye diseases.-Fineline Info & Tech