Innovent Biologics, Inc. announced that the first patient with thyroid eye disease (TED) has been successfully dosed in the phase 3 study (RESTORE) of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.
The RESTORE study is a randomized, double-blinded, placebo-controlled, phase 3 clinical study evaluating the efficacy of IBI311 in improving proptosis in TED subjects to support the potential new drug application of IBI311. The primary endpoint is the difference in the improvement in proptosis degree responder rate of the study eye in the treatment group compared with the placebo group at week 24.
IBI311 is an IGF-1R targeting monoclonal antibody independently developed by Innovent for the treatment of TED. Currently no biological agent for TED has been approved in China.
By blocking the binding of IGF-1 and IGF-2 to IGF-1R, IBI311 inhibits IGF-1R signaling pathway activation and reduces the expression of downstream inflammatory factors, thereby inhibiting the adipocytosis of orbital fibroblasts (OFs) and the synthesis of hyaluronic acid and other glycosaminoglycans due to the activation of OFs, as well as the inflammatory response, thus reduces disease activity and improve proptosis, diplopia, ocular congestion and edema in patients with TED.
The principal investigator, Professor Fan Xianqun from Ophthalmology Department of the Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, an academician from the Chinese Academy of Engineering, stated:
"TED is one of the most common orbital diseases in adults and is an organ-specific autoimmune disease closely related to thyroid disease, which can severely affect the visual function and appearance of patients. There are currently no targeted drugs approved for TED in China. Significant efficacy signals have been observed in IBI311 phase 2 clinical study, including the regression of exophthalmos and the improvement of the clinical activity score (CAS), and a good safety profile was also demonstrated. We are confident that IBI311, developed by a domestic biopharmaceutical company, will demonstrate good efficacy and safety in the Chinese TED patients and be able to be launched to market as soon as possible to address patients' urgent needs."
Lei Qian, MD, PhD, vice president of Clinical Development of Innovent, stated:
"At present, there is a great unmet medical need for TED because of no targeted drug approved for TED in China. IBI311 is an ophthalmic drug candidate developed by Innovent for the treatment of TED with high druggability, and will potentially add synergic value to our product portfolio in endocrinology and metabolism field. Preclinical in vivo and in vitro studies, the Phase 1 study in healthy volunteers as well as the Phase 2 study in TED subjects demonstrated that IBI311 has favorable safety and tolerability characteristics, and significant efficacy signals were also observed, which has laid a good foundation for the development of phase 3 RESTORE study. Innovent will continue cooperating with academia and advance clinical development under the leadership of Prof. Fan, and plans to submit the NDA after the phase 3 study completion to bring high quality and accessible biologics to Chinese TED patients."