Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its Phase III regulatory study in China for IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has successfully achieved its primary endpoint. The study targeted thyroid eye disease (TED), with a New Drug Application (NDA) currently in preparation.
Thyroid eye disease is an autoimmune disorder affecting the eye tissue and is commonly associated with toxic diffuse thyroid, also known as Graves’ disease (GD). It is the most prevalent orbital-related disease in adults, affecting approximately 25%-50% of GD patients and even those with normal thyroid function. The annual incidence rate of TED is estimated at 16/100,000 for females and 2.9/100,000 for males, with a prevalence rate of 0.1% to 0.3%.
IBI311 works by blocking the binding of IGF-1 and IGF-2 to IGF-1R, thereby inhibiting the activation of the IGF-1R signaling pathway and reducing the expression of downstream inflammatory factors. This mechanism inhibits the adipocytosis of orbital fibroblasts (OFs) and the synthesis of hyaluronic acid and other glycosaminoglycans due to OFs activation.
The RESTORE-1 study demonstrated that at 24 weeks, the study eye protrusion response rate of subjects receiving IBI311 was significantly higher than that of the placebo group: 85.8% for the IBI311 group versus 3.8% for the placebo group, with a difference of 81.9% (95% CI: 69.8% – 93.9%, P<0.001). Throughout the study, IBI311 showed a favorable safety profile with no serious adverse events reported.- Flcube.com
