Zura Bio Exceeds Enrollment Target in Both Hidradenitis Suppurativa (HS) & Systemic Sclerosis (SSc) Phase 2 Studies and Expands Tibulizumab Program

Key Terms

bispecific antibody medical

A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.

baff medical

BAFF is a naturally occurring protein that helps certain immune cells (B cells) grow, survive and produce antibodies; think of it as a fertilizer that encourages those cells to multiply. It matters to investors because drugs that block or enhance BAFF can change the course of autoimmune diseases or B‑cell cancers, so clinical results, approvals or partnerships tied to BAFF-related therapies can strongly affect a biotech company’s value and prospects.

il-17 medical

IL-17 is a small protein produced by immune cells that acts like a smoke alarm, signaling and amplifying inflammation in the body. Investors care because blocking or measuring IL-17 is a common strategy for drugs and diagnostics aimed at autoimmune and inflammatory diseases; changes in clinical trial results, regulatory decisions, or biomarker data around IL-17 can strongly affect the commercial prospects and risk profile of related therapies.

hiscR50 medical

HiSCR50 is a clinical trial measure used in skin disease studies that means a patient has experienced at least a 50% reduction in the number of painful lumps and boils, without new worsening complications. For investors, HiSCR50 is an objective yardstick of a drug’s effectiveness — hitting this threshold in trials can boost a treatment’s chance of regulatory approval, market acceptance, and commercial value, much like a safety rating improving consumer confidence in a new car model.

hiscR75 medical

HiSCR75 is a clinical-trial measure used in dermatology that indicates a 75% or greater reduction in the number of painful skin lesions and abscesses compared with baseline. For investors, it is an objective signal of a drug’s effectiveness in reducing disease burden—similar to saying a treatment cuts the symptom load by three-quarters—which can strongly influence regulatory decisions, market adoption and commercial value.

modified rodnan skin score medical

A clinical measurement that grades how tight or thick a patient’s skin is at multiple body sites, producing a single score used to track severity and change over time. Investors care because this score is a common primary or secondary endpoint in clinical trials for treatments of systemic sclerosis (scleroderma); meaningful improvements can signal a drug is working, affecting regulatory approval prospects, market value, and commercial potential.

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• 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

HENDERSON, Nev.--(BUSINESS WIRE)-- 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 several tibulizumab program updates.

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 Kiran Nistala, MBBS, PhD, Chief Medical Officer of Zura. "With two readouts ahead and a third indication entering the clinic later this year, the Zura team is executing against the potential for tibulizumab to address the needs of patients across a range of immune-mediated diseases.”

Cash and cash equivalents were $225.6 million as of March 31, 2026. Consistent with prior guidance and inclusive of the planned third-indication study, Zura continues to expect its existing cash to fund planned operations through at least the end of 2028.

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