Innovent Biologics announces positive Phase 2 results for Efdamrofusp Alfa in nAMD


In an important development for the treatment of neovascular age-related macular degeneration (nAMD), Innovent Biologics, Inc., a leading biopharmaceutical company, has announced successful results from the second Phase 2 clinical study of Efdamrofusp Alfa, a high-dose recombinant human VEGFR-Fc-Human CR1 fusion protein injection (R&D code: IBI302). This study, involving more than 360 Chinese subjects with nAMD, demonstrated that Efdamrofusp Alfa could be administered every 12 weeks, providing stable and robust visual and anatomical improvements while potentially inhibiting macular atrophy.

The Phase 2 clinical study, which was randomized, double-masked, and active-controlled (NCT05403749), evaluated the efficacy of longer intervals between intravitreal injections of high-dose IBI302 compared to Aflibercept, a current standard treatment. With subjects randomly divided into three groups (IBI302 6.4 mg, IBI302 8.0 mg, and Aflibercept 2.0 mg), the study assessed changes in best corrected visual acuity (BCVA) from baseline to week 40 over a total duration of 52 weeks. The results revealed non-inferior BCVA gains in the IBI302 groups compared to the Aflibercept group, with the IBI302 6.4 mg and 8.0 mg groups showing mean BCVA improvements of 10.5 and 11.0 ETDRS letters, respectively, versus 9.8 ETDRS letters in the Aflibercept group.

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Notably, approximately 81% to 88% of subjects in the IBI302 groups were able to extend the dosing interval to every 12 weeks, demonstrating the drug’s potential for less frequent dosing. The safety profile of IBI302 was favorable and comparable to that of Aflibercept, with no new safety signals identified.

Professor Xiaodong Sun, the Principal Investigator of the Study and Head of National Center for Clinical Ophthalmology at Shanghai General Hospital, highlighted the significance of these findings. “Intravitreal injection of anti-VEGF drugs is the first-line treatment for nAMD, yet the need for frequent injections and gradual loss of visual benefits remain challenges. IBI302’s success in this Phase 2 study marks a significant step towards meeting these clinical needs, promising a new treatment option for nAMD patients,” said Professor Sun.

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Dr. Lei Qian, Vice President of Clinical Development at Innovent, emphasized the importance of extending dosing intervals and reducing macular atrophy occurrence in nAMD drug development. “IBI302 not only improved BCVA and macular edema in nAMD patients but also extended dosing intervals and showed potential in preventing macular atrophy. We are eager to further explore IBI302’s efficacy and safety in the upcoming Phase 3 STAR trial,” stated Dr. Qian.

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This announcement marks a pivotal moment in the treatment of nAMD, offering hope for a new generation of anti-VEGF agents that can provide lasting benefits with less frequent dosing. As the clinical development of Efdamrofusp Alfa progresses, its potential to change the treatment landscape for nAMD patients worldwide becomes increasingly apparent.

The results from Innovent Biologics’ Phase 2 clinical studies of Efdamrofusp Alfa represent a significant advancement in the treatment of neovascular age-related macular degeneration. By successfully extending the dosing interval while maintaining visual and anatomical benefits, this therapy could significantly reduce the burden of treatment for patients and improve adherence. The potential to inhibit macular atrophy further distinguishes Efdamrofusp Alfa as a promising candidate in the field of nAMD treatments, potentially setting a new standard in patient care.

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