Innovent Presents Groundbreaking Phase 2 Data on Efdamrofusp Alfa at ARVO 2025 Conference
Innovent's Phase 2 Data on Efdamrofusp Alfa at ARVO 2025
Innovent Biologics, Inc., a notable player in the biopharmaceutical industry, has recently made headlines by presenting the results of its Phase 2 clinical trial for Efdamrofusp Alfa (IBI302) at the prestigious ARVO 2025 Annual Meeting in Salt Lake City, Utah. This event brought together experts in vision and ophthalmology from around the world, offering a platform for sharing groundbreaking research and innovations. As a recombinant human vascular endothelial growth factor receptor (VEGFR) and human complement receptor 1 (CR1) bispecific fusion protein, Efdamrofusp Alfa aims to address the needs of patients suffering from neovascular age-related macular degeneration (nAMD).
Scheduled from May 4 to May 8, 2025, the ARVO meeting is a key gathering for researchers and healthcare professionals seeking to improve patient outcomes through science. Innovent's oral presentation, led by Professor Xiaodong Sun from Shanghai General Hospital, offered significant insights into the performance of Efdamrofusp Alfa over a treatment period of one year.
Key Findings from the Phase 2 Trial
The study involved a total of 132 subjects with nAMD, divided into three groups receiving either 6.4 mg or 8.0 mg of IBI302, or the standard of care, Aflibercept at 2.0 mg. The primary objective was to measure the change in best corrected visual acuity (BCVA) from the baseline to week 40 of treatment. Both IBI302 dosing groups showed competitive results compared to Aflibercept, with BCVA improvements of +10.5 and +11.0 letters, respectively, demonstrating no significant difference between the treatments.
Notably, about 80% of the subjects in the IBI302 groups were able to sustain these visual benefits with a dosing interval of up to 12 weeks. This extended dosing frequency stands to alleviate the burden of regular injections that often challenge patient adherence, a crucial factor in managing chronic conditions like nAMD.
Anatomical Improvements
In addition to maintaining visual acuity, the trial data revealed that IBI302 led to a greater reduction in central subfield thickness compared to Aflibercept. Specifically, the reductions in CST were measured at 154.58 μm for the 6.4 mg group and 174.69 μm for the 8.0 mg group, compared to a lesser 131.18 μm reduction for Aflibercept. These anatomical changes further support the efficacy of Efdamrofusp Alfa as a treatment option for patients with this debilitating condition.
Safety Profile
Safety was also closely monitored throughout the trial, and the incidence of adverse events in the IBI302 groups was comparable to that of Aflibercept, with no new safety signals being identified. Importantly, no cases of retinal vasculitis were reported, reaffirming the ongoing commitment to patient safety in clinical research.
Comments from the Research Team
Professor Sun expressed his enthusiasm about sharing these findings with the global ophthalmic community, highlighting the importance of improving patient compliance by minimizing treatment burdens. He stated, “Innovent's vision to offer innovative treatments aligns with our study's aim. The results of IBI302 show promise in enhancing visual acuity and offer potentially extended dosing options that could change how providers manage nAMD.”
Dr. Lei Qian, Innovent's Senior VP of Clinical Development, echoed the positive results, stating, “We are dedicated to advancing IBI302 through subsequent clinical phases to ensure that patients have access to effective, innovative therapies.”
The Path Ahead
Efdamrofusp Alfa stands as a beacon of hope for individuals living with nAMD, with an emphasis on achieving better outcomes through tailored treatment strategies. As innovations in biopharmaceuticals continue to evolve, the groundwork laid by studies like this one could lead to improved quality of life for millions of patients. Innovent Biologics is well-positioned to drive these advancements forward, underscoring its role as a leader in the biopharmaceutical space.
In conclusion, the future looks promising for Efdamrofusp Alfa, with ongoing trials looking to solidify its position in ophthalmologic therapy. As Innovent races toward Phase 3 trials, the potential benefits to nAMD patients are encouraging and warrant close attention from both the medical community and patients alike.