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Phase III thyroid eye disease trial of Innovent fulfils primary endpoint

The antibody IBI311 showed favorable safety in Thyroid Eye Disease (TED) patients. Innovent Biologics disclosed positive results from the Phase III RESTORE-1 trial in Chinese TED patients, meeting its primary endpoint. IBI311, an anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, underwent a randomized, multicenter, placebo-controlled, double-masked trial to assess its TED treatment efficacy and safety.

The study demonstrated a significantly higher proptosis responder rate in the treated group at week 24 (85.8% versus 3.8%). Secondary endpoints, such as achieving a clinical activity score (CAS) of zero or one and a mean change in proptosis from baseline, were also met. With no reports of any serious adverse events, the safety profile was favourable.The Phase III data aligns with Phase II findings, prompting Innovent to prepare an NDA submission for IBI311 to the NMPA Center for Drug Evaluation for TED treatment. Additionally, Innovent initiated the Phase III CLEAR trial for picankibart, an IL23p19 antibody, in moderate-to-severe plaque psoriasis patients in February 2023.