Innovent Doses First Patient in Phase III Trial to Treat Thyroid Eye Disease

Innovent Biologics has recently reported the successful dosing of the first patient in a Phase 3 study of a new targeted drug for thyroid eye disease (TED).

The study, called RESTORE, is a randomized, double-blinded, placebo-controlled clinical study that aims to assess the efficacy of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in improving proptosis in TED patients. The goal is to support the potential new drug application of IBI311.

The primary endpoint of the study is the difference in the improvement in proptosis degree responder rate between the treatment group and the placebo group at week 24.

“By blocking the binding of IGF-1 and IGF-2 to IGF-1R, IBI311 inhibits IGF-1R signalling 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,” Innovent Biologics explained.

Professor Fan Xianqun from the Ophthalmology Department of the Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, who is the principal investigator, stated that at present there are no targeted drugs authorized for treating thyroid eye disease (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,” said Professor Fan Xianqun.

Dr Lei Qian, Vice President of Clinical Development at Innovent, has stated that there is currently a significant unmet medical need in China, as there are no targeted drugs that have been approved for the treatment of thyroid eye disease (TED).

“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 the 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 favourable 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,” he said.

He added that the company plans to continue collaborating with academia and advance clinical development under the guidance of Professor Fan Xianqun. In addition, Innovent intends to submit a New Drug Application (NDA) following the completion of the Phase 3 study in order to provide high-quality and accessible biologics to Chinese patients with thyroid eye disease.