Zura Bio's tibulizumab misses primary endpoint in Phase 2 hidradenitis suppurativa trial

Zura Bio Limited announced on November 9, 2026 that its Phase 2 TibuSHIELD study of tibulizumab (ZB-106) in adults with moderate-to-severe hidradenitis suppurativa did not meet its primary endpoint of percentage change from baseline in total abscess and inflammatory nodule count at Week 16 in either the 300 mg or 150 mg treatment arm.¹ Key secondary endpoints, including HiSCR50 and HiSCR75, were also not met.¹

TibuSHIELD was a global, randomized, double-blind, placebo-controlled Phase 2 trial that enrolled 247 participants randomized 1:1:1 to one of two tibulizumab dose regimens or placebo.¹

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.¹ HiSCR50 response rates were 48.0% and 52.7% for the tibulizumab 300 mg and 150 mg arms, respectively, versus 45.5% for placebo.¹ HiSCR75 response rates were 35.3% and 34.0% for the tibulizumab 300 mg and 150 mg arms, respectively, versus 28.1% for placebo.¹

On safety, any treatment-emergent adverse events occurred in 52.4% of both the 300 mg and 150 mg tibulizumab arms versus 46.3% on placebo, with treatment-emergent serious AEs in 6.1%, 3.7%, and 1.2% of those arms respectively.¹ One death from cardiac arrest occurred in a participant with multiple cardiovascular risk factors in the 300 mg arm and was judged by the site investigator to be unrelated to study treatment.¹

Based on these results, Zura is discontinuing development of tibulizumab in hidradenitis suppurativa.¹ The company said it remains committed to the ongoing TibuSURE study in systemic sclerosis, with topline data expected in H1 2027, and to the planned NEXUS-PMR study in polymyalgia rheumatica, with data expected in Q4 2028.¹ As of September 30, 2026, Zura had cash and cash equivalents of $187.7 million, which it said is sufficient to support planned operations through at least the end of 2028.¹