Innovent's SYCUME® Meets Primary Endpoint in Phase 3 RESTORE-3 Study

Innovent Biologics has announced that its SYCUME® (teprotumumab N01 injection) Phase 3 RESTORE-3 study successfully met its primary endpoint in participants with inactive Thyroid Eye Disease (TED).

The study demonstrated that SYCUME® significantly improved proptosis, achieving a response rate of 60.4% and a least squares mean change from baseline of -1.88 mm. The treatment also exhibited a favorable safety profile among participants.

Thyroid Eye Disease is an autoimmune condition that can cause bulging eyes (proptosis) and other symptoms significantly impacting quality of life. In its inactive phase, the disease is not actively progressing, but symptoms can be persistent.

The results from the RESTORE-3 study suggest that SYCUME® may offer a new therapeutic option for individuals experiencing inactive TED. Innovent Biologics is proceeding with discussions with regulatory authorities regarding potential marketing applications based on these findings.