Zura Bio has discontinued the clinical development of tibulizumab (ZB-106) in hidradenitis suppurativa (HS) after the investigational compound failed to meet its primary and secondary endpoints in the Phase II TibuSHIELD study.
The placebo-controlled, randomised, double-blind trial (NCT06993610) assessed percentage change from baseline in total abscess and inflammatory nodule counts at week 16 across two dose strengths in adults with moderate-to-severe disease. The Phase II TibuSHIELD trial was initiated by the company in May 2025.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It evaluated 247 participants randomised across 150mg (N=82) and 300mg (N=82) tibulizumab arms or a placebo cohort (N=83).
Participants receiving 150mg and 300mg experienced reductions in abscess and inflammatory nodule counts of 58.1% and 56.0%, respectively, compared with 52.5% for placebo.
Key secondary endpoints, including HiSCR50 and HiSCR75 response rates, also failed to demonstrate meaningful differentiation from placebo.
Tibulizumab was well tolerated, with safety findings aligning with known profiles for interleukin-17 (IL-17) and B-cell activating factor (BAFF) inhibition.
One death from cardiac arrest occurred in the 300mg cohort, which the site investigator considered unrelated to treatment in a patient with multiple cardiovascular risk factors, alongside one adverse event of special interest involving worsening inflammatory bowel disease.
Zura CEO Sandeep Kulkarni said: “We are disappointed to report that the TibuSHIELD study was unable to deliver a positive outcome for patients. Despite TibuSHIELD being a large and well-controlled study, these results highlight the challenges of developing medicines in HS, including the high variability of placebo responses.
“We are conducting a full analysis of the data to understand what it tells us about the biology of HS, the impact of tibulizumab, and the roles of IL-17 and BAFF. We are grateful to the patients, caregivers, and investigators whose participation and commitment made this study possible.”
Zura will continue advancing tibulizumab for systemic sclerosis in the Phase II TibuSURE study (NCT06843239), with topline results expected in the first half of 2027, and plans to initiate the Phase II NEXUS-PMR study in polymyalgia rheumatica by the end of 2026.
Financially, Zura reported cash and cash equivalents of $187.7m as of 30 September 2026. The company expects this capital to fund its planned operations through at least the end of 2028.
