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Innovent Biologics meets primary endpoint for Phase 3 clinical trial, plans to submit NDA


A treatment option for thyroid eye disease may be on its way to finalization in China with the positive endpoint results from a Phase 3 clinical trial of IBI311, a recombinant anti-insulin-like growth factor 1 receptor antibody.

Physician palpating patient's neck Image Credit: AdobeStock/Seventyfour

Image Credit: AdobeStock/Seventyfour

Biopharmaceutical company Innovent Biologics announced that its Phase 3 trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) has met its primary endpoint and is planning to submit a new drug application for treatment of thyroid eye disease (TED) to the Center of Drug Evaluation of the National Drug Administration NMPA.1 IBI311 is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, according to a news release.

Performed on Chinese participants, the endpoint of the multicenter, randomized, double-masked, placebo-controlled Phase 2/3 study was to measure to proptosis responder rate of the study eye (defined as percentage of subjects with a ≥2mm reduction from baseline in proptosis in the study eye without deterioration [≥2 mm increase] of proptosis in the non-study eye).2 The results of the trial found that the proptosis responder rate in the study eye were overwhelmingly higher in participants treated with IBI311 compared to those treated with placebo (85.8% vs. 3.8). Therefore, the introduction of IBI311 had a 81.9% greater impact to the study eye. Additionally, all secondary outcomes, consisting of overall responder rate, percentage of subjects with a clinical activity score (CAS) of 0 or 1, mean changes of both CAS and baseline in proptosis measure, and proptosis and diplopia responders of the study eye all yielded positive outcomes.1

"As an organ-specific autoimmune disease closely related to thyroid disease, TED is one of the most common orbital diseases in adults, and seriously affects the visual function and appearance of patients,” said Professor Xianqun Fan, MD, PhD, the leading principal investigator of the study from the Academician of the Chinese Academy of Engineering and professor of ophthalmology at the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. “At present, there is no targeted drug approved for the treatment of TED in China, and the therapeutic approaches are limited. As the principal investigator of the RESTORE-1 study, I am very pleased to see that IBI311 achieved the primary endpoint in the Phase 3 study and showed a favorable safety profile, which again demonstrates the excellent efficacy of IBI311. I look forward to sharing the detailed results of this high-quality study in the near future, and wish its successful NDA submission so as to bring benefits to Chinese TED patients as soon as possible."

The study included about 114 Chinese participants from the ages 18 to 80 years, with inclusion factors including a clinical diagnosis of Graves disease associated with active TED with a CAS ≥3 for at least one eye at screening and baseline. Participants also had moderate to severe active TED, which was not vision-threatening but significantly impacted daily life.2

Currently, IGF-IR target antibody is the only recommended clinical treatment of TED, specifically for first-line therapy for patients with clinically significant proptosis.1

Lei Qian, PhD, vice president of clinical development of Innovent, stated, "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. 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. At the same time, with the approval of SINTBILO (anti-PCSK9 monoclonal antibody), the NDA acceptance of Mazdutide (GLP-1R/GCGR dual agonist), and the endpoints met in phase 3 study of IBI311, Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of cardiovascular and metabolic diseases, endocrinology and ophthalmology. We will continue to work hard to help people pursue a healthy life."

  1. Innovent announces primary endpoint met in the Phase 3 clinical trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in treating thyroid eye disease and plans to submit NDA to the NMPA. Innovent Biologics. News release. Published Feburary 20, 2024. Accessed February 27, 2024. https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=431
  2. A Study of IBI311 in Subjects with Active Thyroid Eye Disease. Innovent Biologics. NCT05795621. Updated February 8, 2024. Accessed February 27, 2024. https://clinicaltrials.gov/study/NCT05795621?cond=Thyroid%20Eye%20Disease&spons=Innovent%20Biologics%20%5C(Suzhou%5C)%20Co.%20Ltd.&rank=1#study-overview
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