IBI311 Achieves Phase 3 Success in Thyroid Eye Disease Trial with NDA Submission Planned

Innovent Biologics, a renowned biopharmaceutical firm, has reported successful Phase 3 clinical trial results for IBI311, a novel recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, in treating Thyroid Eye Disease (TED) in Chinese patients. The RESTORE-1 study, a randomized, double-masked, placebo-controlled trial, demonstrated IBI311's efficacy and safety. The primary endpoint was met with a significant proptosis responder rate in the study eye at Week 24, favoring IBI311 over placebo.

Key secondary endpoints, including overall response rate, clinical activity score improvement, and mean change in proptosis, also showed substantial improvements with IBI311 treatment. Notably, the medication displayed a positive safety profile with no serious adverse events reported during the study.

TED is an autoimmune disorder affecting the eye, with a higher incidence rate in women and a significant impact on patients' vision and appearance. Currently, no targeted drug for TED is approved in China, despite international guidelines endorsing IGF-IR targeted antibodies as a treatment option.

The principal investigator of the study, Professor Xianqun Fan, expressed satisfaction with IBI311's Phase 3 results and its potential benefits for Chinese TED patients. Dr. Lei Qian, Innovent's Vice President of Clinical Development, highlighted the company's commitment to addressing unmet medical needs and bringing quality biological drugs to Chinese TED patients.

Innovent Biologics, founded in 2011, is dedicated to providing affordable high-quality biologics for various diseases, including cancer, cardiovascular, metabolic, autoimmune, and eye conditions. With ten marketed products and a robust pipeline, Innovent collaborates with global healthcare leaders to advance biopharmaceutical treatments.

The company operates under a strict ethical code and is committed to maintaining industry standards and collaborating to make top-tier pharmaceuticals widely accessible.