Innovent Biologics Triumphs in Phase 3 Study of TED Treatment in China

Innovent Biologics announced the successful achievement of the primary endpoint in the phase 3 registrational study, RESTORE-1, of IBI311 in China. This recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody marks a pivotal advancement in the treatment of thyroid eye disease among Chinese subjects.

Study Highlights

The RESTORE-1 study, a multicenter, randomized, double-masked, placebo-controlled phase 2/3 trial, was designed to assess the efficacy and safety of IBI311. Demonstrating remarkable success, the study revealed that at week 24, subjects treated with IBI311 experienced a significantly higher proptosis responder rate in the study eye compared to those administered a placebo, recording an astounding 85.8% vs. 3.8%.

Moreover, IBI311 showcased superiority across key secondary endpoints, including the overall response rate, the percentage of subjects achieving a clinical activity score (CAS) of 0 or 1, and mean change in proptosis from baseline, solidifying its effectiveness and potential as a groundbreaking treatment option.

Commitment to Safety and Efficacy

Reinforcing its commitment to safety, IBI311's overall safety profile was favorable, with no serious adverse events reported, aligning with the promising results observed in its phase 2 segment. These findings pave the way for IBI311's anticipated introduction to the Chinese market, addressing a significant unmet medical need in the realm of TED treatment.

"There are no targeted drugs approved in the field of TED in China so far, while the treatment costs of overseas targeted drugs are beyond many patients' reach. Driven by the focus of addressing patients' unmet medical needs, we advanced the development of IBI311 rapidly," said Dr. Lei Qian, Vice President of Clinical Development of Innovent. "IBI311 has demonstrated significant efficacy and favorable safety in the treatment of TED in the RESTORE-1 study. We plan to submit its NDA as soon as possible, and bring high-quality, effective and safe biological drugs to Chinese patients with TED."

Future Directions

Innovent plans to submit the New Drug Application (NDA) for IBI311 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China imminently, aspiring to make this high-quality, effective, and safe biological drug accessible to Chinese patients grappling with TED.