Innovent Biologics Concludes Phase 3 Trial To Treat Thyroid Eye Disease

The initial conclusion in the phase 3 study of IBI311, clinical trial involving Chinese subjects with thyroid eye disease (TED) has been completed using a recombinant antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), according to Innovent Biologics, Inc., a world-class leading biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, and other Innovent plans to present the new medication application (NDA) for IBI311 in the treatment of TED to the Middle for Medication Assessment (CDE) of the Public Medication Organization (NMPA).

RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye (the percentage of subjects. The proportion of study participants who experienced a decrease in proptosis of 2 millimeters or more in the treated eye, without a worsening of proptosis by 2 millimeters or more in the other eye, was significantly higher in those who received treatment with IBI311 compared to those who received a placebo. 85.8% vs. 3.8%, with a difference of 81.9% (95% CI: 69.8% to 93.9%, P < 0.0001), as per pharmabiz.

The key secondary endpoints of the study, including the overall response rate (the percentage of subjects with a reduction in proptosis of =2 mm from baseline and improvement in clinical activity score =2 in the study eye), the percentage of subjects with a clinical activity score of 0 or 1, and the mean change in proptosis from baseline in the study eye, were also met successfully. IBI311 significantly outperformed the placebo in all of the aforementioned parameters.