Zura Bio (ZURA) details Phase 2 TibuSURE systemic sclerosis trial design
Rhea-AI Filing Summary
Zura Bio Limited filed a current report describing a press release about its Phase 2 TibuSURE study of tibulizumab (ZB-106) in diffuse cutaneous systemic sclerosis. The company will present the study design as a poster at the 9th Systemic Sclerosis World Congress in Athens.
The global, randomized, double-blind, placebo-controlled Phase 2 trial is expected to enroll about 80 adults, treated every four weeks for 24 weeks, followed by a 28‑week open-label extension. The primary endpoint is change in modified Rodnan Skin Score at Week 24, with topline results anticipated in the first half of 2027.
Tibulizumab is an investigational dual-pathway antibody targeting IL-17A and BAFF. Zura highlights that no clinical efficacy or safety data will be presented in the poster; it focuses on study rationale and design only.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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Item 7.01. Regulation FD Disclosure.
On March 5, 2026, Zura Bio Limited (the “Company”) issued the press release attached hereto as Exhibit 99.1 to this Current Report on Form 8-K. By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
The information presented in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Press Release, dated March 5, 2026 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZURA BIO LIMITED | ||
| Date: March 5, 2026 | By: | /s/ Kim Davis |
| Kim Davis | ||
| Chief Operating Officer, Chief Legal Officer and Corporate Secretary | ||
Exhibit 99.1
Zura Bio to Present Phase 2 TibuSURE Study Design Poster Evaluating Dual IL-17A and BAFF Inhibition in Systemic Sclerosis at 9th Systemic Sclerosis World Congress
HENDERSON, Nev. – (BUSINESS WIRE) – March 5, 2026 – 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 that the design of its ongoing Phase 2 TibuSURE clinical trial evaluating tibulizumab (ZB-106) in systemic sclerosis (SSc) has been accepted for poster presentation at the Systemic Sclerosis World Congress, taking place March 5–7, 2026 in Athens, Greece.
The poster, titled “TibuSURE: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis” (Abstract ID 184; Poster P.267), outlines the rationale and design of the global Phase 2 study. No clinical efficacy or safety data will be presented.
Diffuse cutaneous systemic sclerosis (“dcSSc”) is a rare, progressive autoimmune disease characterized by immune activation, vasculopathy and fibrosis affecting the skin and internal organs, including the lungs. Treatment options remain limited, highlighting the need for therapeutic approaches that address multiple drivers of disease biology.
TibuSURE is the first clinical trial designed to evaluate the dual inhibition of interleukin-17A (“IL-17A”) and B-cell activating factor (“BAFF”) in dcSSc. Tibulizumab is an investigational bispecific antibody engineered to simultaneously neutralize IL-17A and BAFF, two cytokines implicated in inflammation, autoimmunity and fibrotic progression in SSc. By targeting complementary immune pathways, tibulizumab represents a differentiated investigational strategy intended to modulate both inflammatory and fibrotic disease processes.
The ongoing global Phase 2 study is expected to enroll approximately 80 adults who will be randomized 1:1 to receive tibulizumab or placebo every four weeks for 24 weeks, followed by a 28-week open-label extension. The primary endpoint is change from baseline in modified Rodnan Skin Score at Week 24. Topline results are currently anticipated in the first half of 2027.
Poster Presentation Details
| · | Poster Number: P.267 |
| · | Presenting Author: Christopher Denton, M.D., Ph.D., FRCP, Professor of Experimental Rheumatology at University College London |
| · | Session Times (Local Athens Time, EET / UTC+2): |
| – | Friday, March 6, 2026: 13:20–14:25 |
| – | Saturday, March 7, 2026: 12:35–13:50 |
ABOUT TIBULIZUMAB (ZB-106)
Tibulizumab is an investigational, humanized, tetravalent dual-antagonist antibody engineered by fusing Taltz® (ixekizumab) and tabalumab to bind to and neutralize both IL-17A and BAFF. It is currently being evaluated in two Phase 2 clinical studies in adults with hidradenitis suppurativa and systemic sclerosis. Prior to in-licensing by Zura, Phase 1/1b studies were conducted in patients with Sjögren’s syndrome and rheumatoid arthritis.
Tibulizumab is an investigational compound and has not been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority.
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 being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa (HS), and TibuSURE, a study in systemic sclerosis (SSc). Additional product candidates crebankitug (ZB-168) and torudokimab (ZB-880) 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 “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Zura’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Zura’s product candidates; the timing of enrollment, initiation, progress, and results of Zura’s current and future clinical trials, including TibuSURE, including reporting of data therefrom; and Zura’s plans to present the design of its Phase 2 TibuSURE clinical trial at the Systemic Sclerosis World Congress. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Zura’s current or future product candidates will 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, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Zura’s current or future product candidates; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, will not be replicated in ongoing or future studies or clinical trials involving Zura’s current or future product candidates; the risk that Zura’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Zura anticipates; risks regarding 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; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties that are described in Zura’s Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025 and September 30, 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, and 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.
CONTACT
Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Filing Exhibits & Attachments
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