9/103 sources · 2 publishersUpdated Oct 9, 08:26 UTC
Innovent’s SYCUME meets Phase 3 endpoint in inactive thyroid eye disease
Innovent Biologics said on October 8, 2026 that its SYCUME Phase 3 RESTORE-3 study met its primary endpoint in Chinese participants with inactive thyroid eye disease. Among 116 participants, the treatment produced a 60.4% proptosis response rate at Week 24 and a least-squares mean change from baseline of -1.88 mm. Innovent reported a favorable safety profile, with no new safety signals identified.
Why it matters
The results add Phase 3 clinical evidence for SYCUME in inactive thyroid eye disease, a later-stage population with persistent proptosis. Follow-up is still ongoing, and the complete data have not yet been published.
Key facts
- 1RESTORE-3 was a randomized, double-blind, placebo-controlled Phase 3 study involving 116 participants with inactive thyroid eye disease. prnewswire.com
- 2At Week 24, the SYCUME group had a 60.4% proptosis response rate versus 23.5% for placebo, a treatment difference of 36.9 percentage points. prnewswire.com
- 3The least-squares mean change from baseline in study-eye proptosis was -1.88 mm for SYCUME versus -0.88 mm for placebo. prnewswire.com
- 4SYCUME was included in China’s National Reimbursement Drug List on January 1, 2026. prnewswire.com
- 5The company reported that most treatment-emergent adverse events were mild to moderate and that no new safety signals were identified. prnewswire.com
Open questions
- Follow-up of RESTORE-3 is still ongoing, and the complete data are expected to be published in future academic conferences or peer-reviewed academic journals.
- The reported findings are from a company announcement and do not yet include the complete study dataset.
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.