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Zura Bio Provides Clinical Update on Phase 2 TibuSHIELD Study of Tibulizumab (ZB-106) in Hidradenitis Suppurativa

  • Zura Bio Limited's Phase 2 TibuSHIELD trial for tibulizumab in moderate-to-severe hidradenitis suppurativa failed to meet its primary endpoint of percentage change from baseline in total abscess and inflammatory nodule count at Week 16.
  • Key secondary endpoints including HiSCR50 and HiSCR75 response rates were not met across both 300 mg and 150 mg treatment arms.
  • Although tibulizumab arms showed slightly higher percentage reductions in abscess and nodule counts compared to placebo, the differences were not statistically significant enough to meet efficacy criteria.
  • Zura is discontinuing the development of tibulizumab for hidradenitis suppurativa due to these results.
  • Both tibulizumab doses were well tolerated, with safety profiles consistent with established IL-17 and BAFF inhibition, including one death unrelated to treatment and one case of inflammatory bowel disease exacerbation.
  • The ongoing TibuSURE trial in systemic sclerosis will continue, with topline data expected in the first half of 2027.
  • The planned NEXUS-PMR trial in polymyalgia rheumatica will proceed, with data anticipated in the fourth quarter of 2028.
  • Additional analyses regarding pharmacokinetics, exposure-response relationships, and HS-specific factors are ongoing to understand the biological implications of the trial results.
  • Zura maintains sufficient cash and cash equivalents of $187.7 million as of September 30, 2026, to support operations through at least the end of 2028.