Biopharmaceutical Era October 21, 2024 10:04 Zhejiang

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On October 21, 2024, Xinda Biotechnology announced the Phase II clinical data of its recombinant human vascular endothelial growth factor receptor (VEGFR) - antibody human complement receptor 1 (CR1) fusion protein Efdamrofusp alfa injection (R&D code: IBI302) in neovascular age-related macular degeneration (nAMD) at the 2024 American Academy of Ophthalmology (AAO) Annual Meeting. This presentation attracted the attention of many attending experts and scholars.
Phase II clinical study of IBI302 (anti VEGF and anti complement dual target drug) administered at long intervals in subjects with neovascular age-related macular degeneration
The data released this time comes from the Phase II clinical study of IBI302, aimed at evaluating the efficacy, safety, and dosing interval of high-dose IBI302 in the treatment of nAMD (study registration number: NCT05403749). 132 subjects were randomly assigned in a 1:1:1 ratio to the IBI302 6.4mg group, IBI302 8.0mg group, and aflibercept 2.0mg group. After load therapy, the IBI302 6.4mg and 8.0mg groups were adjusted to be administered every 8 weeks (Q8W) or every 12 weeks (Q12W) until the end of the study based on treatment response. After loading therapy with 2.0 mg of aflibercept, it was administered according to Q8W until the end of the study. The primary endpoint of the study was the change in the best corrected visual acuity (BCVA) score of the eye compared to baseline at week 40.
The research results show that:
At week 40, the improvement of BCVA in the IBI302 6.4 mg group and 8.0 mg group was non inferior to that in the aflibercept 2.0 mg group. At week 40, the mean changes in BCVA from baseline in the IBI302 6.4 mg group, IBI302 8.0 mg group, and aflibercept 2.0 mg group were+10.5,+11.0, and+9.8 ETDRS letters, respectively.
At the anatomical efficacy endpoint, at week 40, the mean changes in central subfield thickness (CST) from baseline were -163.19 μ m and -184.46 μ m in the IBI302 6.4 mg and 8.0 mg groups, respectively, and -108.23 μ m in the aflibercept 2.0 mg group.
The potential for long-term dosing of IBI302 was observed: the proportion of subjects in the 6.4mg and 8.0mg IBI302 groups who maintained the Q12W dosing interval was 81% and 88%, respectively.
In terms of safety, the safety features of IBI302 are consistent with previous studies, with overall good safety, similar to the 2.0 mg group of aflibercept. No new security signals were found.
The main researcher of this clinical study, Professor Sun Xiaodong, Vice President of the First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of the Ophthalmic Clinical Medicine Center, said: "Anti VEGF drugs are currently the first-line treatment choice for neovascular age-related macular degeneration (nAMD), which can delay disease progression, but frequent injections and visits affect patient treatment compliance. Developing multi-target and exploring long interval administration is a new trend in drug development. IBI302 is the world's first anti VEGF and anti complement dual target molecule, and high-dose IBI302 has shown good efficacy, achieving the main research endpoint and observing the potential of long interval administration. I am very much looking forward to these results in the current nAMD phase III clinical study. To bring new treatment options for more nAMD patients as soon as possible
Dr. Qian Lei, Senior Vice President of Xinda Biopharmaceutical Group, said, "We are pleased to once again share the latest research and development progress of the high-dose phase II clinical trial of Xinda Biopharmaceutical's ophthalmic product IBI302 at the American Ophthalmology Annual Meeting (AAO). The high-dose IBI302 has shown positive therapeutic effects, including improved vision, improved anatomical structure, and potential for long-term dosing; the trial did not produce any new safety signals, further proving the safety of the drug. These exciting results provide a solid foundation for our next research and development work. We look forward to continuing to work with clinical experts to accelerate the completion of phase III clinical trials and bring this innovative drug to nAMD patients as soon as possible