CHINA —Chinese biopharmaceutical company Innovent Biologics has announced a key milestone for its drug for thyroid eye disease (TED), an autoimmune disease involving ocular tissues, with a significant impact on visual function and appearance.  

In a statement, the company noted that it had successfully achieved the primary endpoint for the Phase 3 registrational study (RESTORE-1) of IBI311 in Chinese subjects with  TED. 

IBI311 is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, .RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with TED.  

The study has demonstrated significant progress, meeting its primary objective. 

By Week 24, a remarkable improvement was observed in a higher percentage of individuals treated with IBI311 compared to those who received a placebo.  

Specifically, 85.8% of those treated with IBI311 showed improvement, while only 3.8% of those who received a placebo did, marking a significant margin of 81.9%. 

Moreover, other crucial measures in the study, including the overall response rate and clinical activity score, exhibited significant improvement in participants treated with IBI311 compared to the placebo. 

The safety profile of IBI311 remained favorable throughout the study, with no serious adverse events reported. 

The efficacy and safety observed in the Phase III portion were consistent with the data from Phase II. 

With the latest results, the company is preparing to file an NDA for IBI311 with the NMPA Center for Drug Evaluation to treat TED. 

“We plan to submit its NDA as soon as possible and bring high-quality, effective and safe biological drugs to Chinese patients with TED,” said Innovent Clinical Development Vice-president Dr Lei Qian. 

Professor Xianqun Fan, the leading principal investigator of the study, said “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.” 

 Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of cardiovascular and metabolic diseases (CVM), endocrinology and ophthalmology. 

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 are all testament that the company is gradually moving closer to this goal.  

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