Innovent Announces Primary Endpoint Met in the Phase 3 Trial of TED Candidate; Plans to Submit NDA in China
Innovent Biologics announced that the primary endpoint has been achieved in the phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA) in China.
RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at week 24, the proptosis responder rate in the study eye (the percentage of subjects with a reduction in proptosis of ≥2 mm from baseline in the study eye without deterioration ≥ 2 mm increase of proptosis in the fellow eye) was significantly higher in subjects treated with IBI311 than in subjects treated with placebo: 85.8% vs. 3.8%, with a difference of 81.9% (95% CI: 69.8% to 93.9%, P<0.0001).
In addition, the key secondary endpoints of the study such as overall response rate (the percentage of subjects with a reduction in proptosis of ≥2 mm from baseline and improvement in clinical activity score ≥2 in the study eye), percentage of subjects with a clinical activity score (CAS) of 0 or 1, and mean change in proptosis from baseline in the study eye were successfully met: IBI311 significantly improved all the above parameters as compared to the placebo.
The overall safety profile of IBI311 was favorable throughout the study with no serious adverse events occurred. The efficacy and safety profiles in the phase 3 part of the RESTORE-1 study were consistent with its phase 2 results. Detailed results from the study will be released in medical conferences or journals in the future, according to Innovent.
As an autoimmune disease involving ocular tissues, the annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men, [1] and the estimated prevalence of clinically relevant TED ranges from 0.1% to 0.3%. [2] At present, there is no targeted drug approved for the treatment of TED in China, while multiple clinical guidelines recommend the use of IGF-IR targeted antibody in the treatment of TED. [3,4,5] Particularly, IGF-IR targeted antibody is recommended as first-line therapy for patients with clinically significant proptosis.
"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."