Core Viewpoint - Innovent Biologics presented promising results from its Phase 2 clinical trial of efdamrofusp alfa (IBI302) for treating neovascular age-related macular degeneration (nAMD), highlighting its efficacy, safety, and potential for extended dosing intervals [1][2][3]. Group 1: Clinical Trial Results - The Phase 2 study involved 132 subjects randomized into three groups: IBI302 6.4 mg, IBI302 8.0 mg, and Aflibercept 2.0 mg, with the primary endpoint being the change in best corrected visual acuity (BCVA) from baseline to week 40 [2][4]. - IBI302 demonstrated competitive efficacy with BCVA gains of +10.5, +11.0, and +9.8 ETDRS letters for the 6.4 mg, 8.0 mg, and Aflibercept groups respectively at week 40, sustained through week 52 [4]. - Over 80% of participants in the IBI302 groups maintained visual benefits with a 12-week dosing interval, indicating potential for reduced treatment burden [4][5]. Group 2: Safety and Efficacy - No new safety signals were identified during the trial, and the incidence of adverse events in IBI302 groups was similar to Aflibercept, with no cases of retinal vasculitis reported [4][5]. - IBI302 showed potential efficacy in inhibiting macular atrophy, with a nearly 40% reduction in incidence compared to Aflibercept (4.9% in IBI302 vs. 8.3% in Aflibercept) [4]. Group 3: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer and eye diseases, and has launched 15 products to date [7]. - The company is actively collaborating with over 30 global healthcare partners and has multiple assets in various stages of clinical trials [7].
Innovent Announces Oral Presentation of Full Phase 2 Clinical Data for Efdamrofusp Alfa (IBI302), First-in-class anti-VEGF/complement Bispecific Fusion Protein at ARVO 2025