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Innovent’s SYCUME Hits Phase 3 Goals for Inactive Thyroid Eye Disease

Innovent Biologics has reported successful results from its RESTORE-3 clinical trial, showing that the antibody SYCUME effectively reduces proptosis in patients with inactive thyroid eye disease. The findings offer a potential non-surgical alternative for thousands of chronic sufferers in China who previously lacked pharmacological treatment options.

Innovent’s SYCUME Hits Phase 3 Goals for Inactive Thyroid Eye Disease
Photo: Bio & News

The multicenter, randomized study enrolled 116 participants to evaluate the efficacy of the IGF-1R antibody, IBI311, against a placebo. By the 24-week mark, 60.4% of patients receiving the treatment achieved a proptosis response, compared to 23.5% in the control group. Furthermore, the treatment group showed a mean reduction in eye protrusion of 1.88 mm, marking a statistically significant improvement over the placebo.

Safety data remained consistent with prior observations, as most adverse events were reported as mild to moderate. Professor Zhongyan Shan of the First Hospital of China Medical University noted that the results validate the use of IGF-1R-targeted therapy beyond the acute inflammatory stage of the disease. This development allows for a broader therapeutic approach, covering both early-stage control and chronic-phase tissue remodeling for patients who have historically relied on complex surgical interventions.

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