Zura Bio Says Phase 2 TibuSHIELD Study Of Tibulizumab In Hidradenitis Suppurativa Missed Primary And Key Secondary Endpoints

• Study did not meet primary endpoint of percentage change from baseline in total abscess and inflammatory nodule (AN) count at Week 16
• Key secondary endpoints, including HiSCR50 and HiSCR75, were not met
• Both doses of tibulizumab were well tolerated; observed safety was consistent with established safety profiles for both IL-17 and BAFF inhibition
• The ongoing TibuSURE trial in systemic sclerosis (SSc) and the planned NEXUS-PMR trial in polymyalgia rheumatica (PMR) will continue, with data expected in H1 2027 and Q4 2028, respectively; Zura is discontinuing development in hidradenitis suppurativa

Zura Bio Limited (NASDAQ:ZURA) ("Zura"), a clinical-stage biotechnology company developing novel and differentiated medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and inflammatory diseases, today announced that its Phase 2 TibuSHIELD study, which evaluated tibulizumab (ZB-106) in adults with moderate-to-severe hidradenitis suppurativa (HS), did not meet its primary endpoint of percentage change from baseline in total abscess and inflammatory nodule (AN) count at Week 16 in either the 300 mg or 150 mg treatment arm. Key secondary endpoints, including HiSCR50 and HiSCR75, were also not met.

TibuSHIELD was a global, randomized, double-blind, placebo-controlled Phase 2 trial evaluating the safety, tolerability, and efficacy of tibulizumab in adults with moderate-to-severe HS. The trial enrolled 247 participants randomized 1:1:1 to receive one of two tibulizumab dose regimens or placebo. The study included a 16-week efficacy assessment period, followed by an optional 16-week open-label extension (OLE), with a 12-week safety follow-up period.

At Week 16, study participants experienced 56.0% and 58.1% reductions from baseline in AN count in the tibulizumab 300 mg and 150 mg arms, respectively, compared with a 52.5% reduction in the placebo arm. HiSCR50 response rates were 48.0% and 52.7% for the tibulizumab 300 mg and 150 mg arms, respectively, versus 45.5% for placebo. HiSCR75 response rates were 35.3% and 34.0% for the tibulizumab 300 mg and 150 mg arms, respectively, versus 28.1% for placebo.