Zura Bio Exceeds Enrollment Target in Both Hidradenitis Suppurativa (HS) & Systemic Sclerosis (SSc) Phase 2 Studies and Expands Tibulizumab Program
- Tibulizumab is the first and only bispecific antibody targeting both BAFF and IL-17 in clinical development
- TibuSHIELD has completed enrollment, exceeding enrollment target with 247 participants randomized in HS; topline data expected Q4 2026
- TibuSURE has exceeded the 80 participant enrollment target in SSc and remains on track to complete enrollment in early July; topline data expected H1 2027
- Zura plans to initiate a Phase 2 study for tibulizumab in a third immune-mediated indication by year end 2026
Zura has completed enrollment of the Phase 2 TibuSHIELD trial of tibulizumab in adults with HS. The TibuSHIELD trial exceeded the target enrollment, with 247 participants enrolled. Zura remains on track to complete enrollment of the Phase 2 TibuSURE trial of tibulizumab in adults with early diffuse cutaneous SSc in early July. The TibuSURE trial has already exceeded the target enrollment of 80 participants. Exceeding enrollment targets in both TibuSHIELD and TibuSURE reflects the significant unmet need facing patients with HS and SSc. Topline data from TibuSHIELD are expected in the fourth quarter of 2026. Topline data from TibuSURE are expected in H1 2027.
Building on tibulizumab's bispecific mechanism targeting both interleukin-17 (“IL-17”) and B cell activating factor (“BAFF”), Zura plans to initiate a Phase 2 study in a third immune-mediated indication by year end 2026. Indication expansion of tibulizumab reflects Zura’s belief in the broad potential of IL-17 and BAFF dual pathway inhibition across immune-mediated diseases. Zura plans to announce the new indication prior to study initiation.
"Meeting these enrollment milestones reflects the hard work of our team and the commitment of the investigators and patients. Tibulizumab targets both IL-17 and BAFF — pathways that together form a compelling rationale across a range of immune-mediated conditions and that we believe can break through efficacy ceilings in complex immune disorders," said
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TibuSHIELD
TibuSHIELD is a global, Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, and efficacy of tibulizumab in adults with moderate to severe HS. Participants were randomized 1:1:1 to receive two different doses of tibulizumab or placebo. The study includes a 16-week efficacy assessment period followed by a 12-week safety follow-up and an optional open-label extension.
The primary endpoint of the study is the percent change from baseline in total abscess and nodule (AN) count at Week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in AN count without an increase in abscesses or draining fistulas at Week 16.
TibuSURE
TibuSURE is a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in adults with early diffuse cutaneous systemic sclerosis. The study includes a 24-week double blind efficacy assessment period followed by an optional open-label period following completion.
The primary endpoint is change from baseline in modified Rodnan Skin Score (mRSS) at Week 24. Secondary endpoints assessing interstitial lung disease include forced vital capacity and quantitative high-resolution computed tomography. TibuSURE is the first clinical trial designed to evaluate the dual inhibition of IL-17 and BAFF in diffuse cutaneous systemic sclerosis.
For additional information, please visit www.clinicaltrials.gov.
ABOUT ZURA
Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. Zura’s pipeline includes product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients.
Zura’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa, and TibuSURE, a study in systemic sclerosis. Zura plans to initiate a Phase 2 study for tibulizumab in a third immune-mediated indication by year end 2026. Additional product candidates, torudokimab (ZB-880) and crebankitug (ZB-168), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions.
For more information, please visit www.zurabio.com.
FORWARD-LOOKING STATEMENTS
Any statements contained in this press release that do not describe historical facts may constitute “forward‑looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “anticipate,” “believe,” “continue,” “could,” “designed to,” “expect,” “goal,” “intend,” “may,” “outlook,” “plan,” “potential,” “should,” “will,” and similar expressions and the negative of such terms, and are based on Zura’s current beliefs and expectations. These forward‑looking statements include, but are not limited to, statements regarding the development and potential therapeutic benefits of tibulizumab; the timing, progress, design and results of Zura’s current and future clinical trials, including the status of enrollment and anticipated reporting of data therefrom; Zura’s plans to initiate a Phase 2 study for tibulizumab in a third immune-mediated indication by year end 2026; the sufficiency of Zura’s cash resources and projected cash runway, and other statements that are not historical facts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward‑looking statements. Risks and uncertainties that may cause actual results to differ materially include, but are not limited to: uncertainties inherent in the development of therapeutic product candidates, such as the risk that one or more of Zura’s current or future product candidates may not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Zura’s current or future product candidates; the risk that prior results, including signals of safety, activity or durability of effect observed in preclinical studies or earlier clinical trials, may not be replicated or may not continue in ongoing or future studies or clinical trials; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, may not be predictive of results in Zura’s current or future clinical trials; the risk that Zura’s product candidates or procedures in connection with their administration may not have the safety or efficacy profiles anticipated; risks related to the accuracy of Zura’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; uncertainties related to the timing and outcome of the regulatory approval process; unexpected litigation or other disputes; the impact of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties to be described in Zura’s Annual Report on Form 10‑K for the year ended December 31, 2025, and other filings with the Securities and Exchange Commission. Any forward‑looking statements speak only as of the date of this press release and are based on information available to Zura as of the date hereof. Zura assumes no obligation to, and does not intend to, update any forward‑looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Source: Zura Bio Limited