China-based biotech Innovent Biologics Inc. (HKG: 1801) announced that the first subject has been dosed in a Phase I clinical study for its IBI311, an insulin-like growth factor 1 (IGF-1R) monoclonal antibody (mAb).
Study Details
The Phase I dosage escalation study (CTR20221581) is designed to assess the safety and tolerability of a single dose of IBI311 in healthy subjects in China. It aims to support the clinical development of the drug in active thyroid-associated ophthalmopathy (TAO).
Mechanism of Action
IBI311 can inhibit the activation of the IGF-1R signaling pathway. It reduces the expression of downstream inflammatory factors by blocking the binding of IGF-1 and IGF-2 to IGF-1R. This mechanism inhibits the activation of adipocytes in orbital fibroblasts (OFs). It avoids the synthesis of hyaluronic acid and other glycosaminoglycans and the inflammatory response caused by the activation of OFs. As a result, it reduces the disease activity of TAO patients and improves symptoms such as exophthalmos, diplopia, ocular congestion, and edema.
Market Context
There is currently no TAO-targeted drug approved for marketing in China. Horizon Therapeutics’ Tepezza (teprotumumab) is the first and only IGF-1R mAb approved in the US to treat TAO.-Fineline Info & Tech