#China #Suzhou #Innovent Biologics #Efdamrofusp Alfa #nAMD

Innovent Biologics' Efdamrofusp Alfa Achieves Key Milestone in nAMD Treatment

In a groundbreaking development, Innovent Biologics, Inc. has reported the successful completion of their Phase 3 STAR study of Efdamrofusp Alfa (IBI302), marking it as the first self-developed, extended-interval treatment for neovascular age-related macular degeneration (nAMD) in China. This milestone not only signifies a win for Innovent but also provides hope for patients suffering from this eye disease.

Study Overview

Conducted with a total of 600 participants across multiple sites, the STAR study evaluated IBI302 against the existing treatment standard aflibercept. Patients in the study received treatment at various intervals, with a significant number achieving an extended dosing schedule that could potentially lessen the treatment burden.

The study's primary endpoint focused on the change in best corrected visual acuity (BCVA) after 52 weeks, an important measure of patients' vision improvement. The results showed that IBI302 had a non-inferiority effect compared to aflibercept, with IBI302 demonstrating a BCVA improvement of 10.37 letters, compared to 10.11 letters for aflibercept.

Dosing Interval and Efficacy

One of the most promising outcomes of the study was that 72.8% of participants on IBI302 could maintain a dosing interval of 16 weeks, which is a significant extension compared to the standard treatment. Additionally, about 86% of participants achieved a dosing interval of 12 weeks or longer during follow-up, with nearly 57% showing no disease activity as early as Week 24. This improvement not only enhances patient compliance but also significantly improves their quality of life by reducing the frequency of required injections.

Macular Atrophy Reduction

Another notable finding was the potential of IBI302 in reducing the incidence of macular atrophy, a common complication in nAMD treatments. The study reported a 50% lower incidence of macular atrophy among patients treated with IBI302 compared to those receiving the standard aflibercept treatment. This aspect underscores the dual-target property of the medication in addressing both vascular abnormalities and inflammatory responses, setting it apart from existing therapies.

Safety Profile

Regarding safety, the results indicated a favorable profile, with adverse events being similar to those noted in the aflibercept group. The majority of these events were mild to moderate and typically resolved quickly, reinforcing the viability of IBI302 as a safe treatment option.

Expert Insights

Professor Xiaodong Sun, the principal investigator of the STAR study, expressed enthusiasm at the results, emphasizing that this innovation establishes a valuable addition to treatment protocols for nAMD patients. He noted that the potential for less frequent dosing could significantly enhance adherence to treatment.

Dr. Lei Qian, the Chief Research and Development Officer at Innovent, echoed this sentiment, affirming that the results pave the way for further development and eventual regulatory submissions. He raised the importance of balancing patient comfort with effective treatment outcomes.

Conclusion

The success of the STAR study represents a significant advance in the treatment of nAMD, particularly within China. With IBI302 poised to become a game changer in ophthalmic care, Innovent Biologics is set to continue making strides toward innovative treatments. They aim to submit a New Drug Application (NDA) soon, which could be pivotal in making this treatment widely accessible to patients in need.

As the industry awaits the regulatory approval, future studies and data will continue to shed light on the long-term benefits of this promising therapy.