20 February 2024 | Tuesday | News
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The trial also successfully met its key secondary endpoints, including the overall response rate, the percentage of subjects achieving a clinical activity score (CAS) of 0 or 1, and the mean change in proptosis from baseline, further highlighting IBI311's significant improvements over placebo.
With a favorable safety profile and no serious adverse events reported, IBI311's efficacy and safety in the Phase 3 trial align with the positive outcomes observed in the Phase 2 studies. Detailed findings from RESTORE-1 are anticipated to be shared at upcoming medical conferences and in scientific journals.
TED, an autoimmune disease affecting the eyes, has no targeted drugs approved for treatment in China, despite its prevalence and significant impact on patients' visual function and appearance. IBI311's success in RESTORE-1 offers hope for addressing this unmet need, with Professor Xianqun Fan, the study's leading principal investigator, expressing enthusiasm for the drug's potential benefits for Chinese TED patients.
Dr. Lei Qian, Vice President of Clinical Development at Innovent, highlighted the lack of targeted TED treatments in China and the prohibitive costs of international therapies. Innovent's rapid advancement of IBI311 aims to provide Chinese patients with an effective and safe biological drug option. With IBI311's anticipated NDA submission, along with the strategic development of its innovative portfolio in cardiovascular, metabolic diseases, endocrinology, and ophthalmology, Innovent continues its commitment to improving health outcomes worldwide.
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