Innovent's IBI302 Phase 2 Trial Meets Primary Endpoint for nAMD Treatment

Innovative Biopharmaceuticals, a leading global company in the development and production of high-quality medicines for diseases such as cancer, metabolic disorders, and autoimmune conditions, has announced a significant milestone in a Phase 2 clinical trial for a new treatment of neovascular age-related macular degeneration (nAMD). The trial focused on efdamrofusp alfa, a novel recombinant human VEGFR-Fc-Human CR1 fusion protein injection, known under the research and development code IBI302.

The Phase 2 study involved over 360 subjects and demonstrated that IBI302 can be administered less frequently, every 12 weeks, compared to the standard treatment Aflibercept, without compromising visual benefits or anatomical improvements. Following these promising results, the company initiated a Phase 3 clinical study called STAR in October 2023.

The Phase 2 study was a randomized, double-masked, and active-controlled trial that assessed the efficacy of high-dose IBI302 administered at longer intervals. The trial included 132 subjects, divided into three groups receiving either IBI302 at 6.4 mg, 8.0 mg, or Aflibercept at 2.0 mg. The primary outcome measure was the change in best corrected visual acuity (BCVA) from baseline to week 40, with a total study duration of 52 weeks.

The findings indicated that at week 40, both IBI302 dosage groups showed non-inferior BCVA improvements compared to the Aflibercept group. The mean BCVA improvement from baseline was 10.5 ETDRS letters for the 6.4 mg IBI302 group, 11.0 ETDRS letters for the 8.0 mg IBI302 group, and 9.8 ETDRS letters for the Aflibercept group. Additionally, the mean central subfield thickness (CST) reduction from baseline was significantly greater in both IBI302 groups compared to the Aflibercept group.

Approximately 81% and 88% of subjects in the 6.4 mg and 8.0 mg IBI302 groups, respectively, were able to extend their dosing interval to every 12 weeks, similar to the proportion of subjects in trials for other treatments. The Phase 3 study STAR has incorporated a new dosing interval of every 16 weeks for IBI302 based on its performance in the Phase 2 studies.

The safety profile of IBI302 was found to be favorable and comparable to Aflibercept, with no new safety concerns identified. Detailed data from the study will be further analyzed and published soon.

Professor Xiaodong Sun, the principal investigator and head of the National Center for Clinical Ophthalmology at Shanghai General Hospital, emphasized the need for treatments that can extend dosing intervals and prevent macular atrophy in nAMD, highlighting IBI302 as a potential new option for patients.

Dr. Lei Qian, Vice President of Clinical Development at Innovative Biopharmaceuticals, noted the importance of extending dosing intervals and reducing macular atrophy in nAMD treatment. The Phase 3 STAR trial will further investigate the efficacy and safety of high-dose IBI302 at extended dosing intervals.

Neovascular age-related macular degeneration (nAMD) is a progressive disease that affects the central vision of patients over 65, and its incidence is rising in China. The condition is primarily caused by angiogenesis induced by VEGF and complement-mediated inflammatory reactions. Current treatments involve frequent injections, which can be burdensome, and visual benefits tend to diminish over time. The development of drugs that can extend dosing intervals and address macular atrophy is a significant focus in the field.

Efdamrofusp Alfa (IBI302) is a bispecific fusion protein with proprietary rights, designed to inhibit both VEGF-mediated angiogenesis and complement activation pathways, offering a dual approach to treating nAMD.

Innovative Biopharmaceuticals, founded in 2011, is dedicated to providing affordable, high-quality biologics for a range of diseases. With a portfolio of 10 marketed products, several in late-stage development, and partnerships with over 30 global healthcare leaders, the company is committed to advancing the biopharmaceutical industry and making top-tier pharmaceuticals widely accessible.