Innovent Biologics, Inc. announced that the first healthy volunteer has been successfully dosed in the Phase 1 study of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody. This study (CTR20221581) is the single dose escalation Phase I study in healthy volunteers aiming to evaluate the safety and tolerability of IBI311 in healthy Chinese subjects after a single dose, thus support the clinical development of IBI311 in active thyroid associated ophthalmopathy (TAO). IBI311 is a monoclonal antibody targeting IGF-1R developed by Innovent for the treatment of active TAO.

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 active TAO. Currently, no targeted drugs for TAO have been approved in China, while in overseas, teprotumumab is the first and currently only IGF-1R mAb approved by the FDA for the treatment of TAO.