Policy & Regulation
Innovent Biologics' IBI311 achieves primary endpoint in phase three registrational study in Chinese subjects with Thyroid Eye Disease
20 February 2024 -

Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company that develops, manufactures and commercialises medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced on Monday that it has achieved the primary endpoint in the phase three registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor one receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED).

The company plans to submit the new drug application (NDA) for the product in the treatment of TED to the Center for Drug Evaluation (CDE) of China's National Drug Administration (NMPA).

RESTORE-1 (CTR20223393), a multicentre, randomised, double-masked, placebo-controlled Phase 2/3 clinical trial, is intended to assess the efficacy and safety of IBI311 in subjects with TED. The company says that the Phase three results of RESTORE-1 indicated that the primary endpoint was successfully met at Week 24. It added that the study's key secondary endpoints were also successfully met.

IBI311's safety profile is claimed to have been favourable throughout the study with no serious adverse events occurred. The efficacy and safety profiles in the Phase three part of the RESTORE-1 study were consistent with its Phase two outcome. Detailed results from the study will be revealed at medical conferences or in journals in the future.