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Zura Bio to Present Data Exploring the Expanded Potential of Tibulizumab (ZB-106) into Sjogren's Syndrome and Rheumatoid Arthritis at EULAR 2024

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Zura Bio, a clinical-stage immunology company, announced its scheduled presentation at EULAR 2024 in Vienna from June 12-15. The company will unveil data on tibulizumab (ZB-106), a dual-pathway antibody targeting IL-17A and BAFF, focusing on its potential for treating Sjogren's syndrome and rheumatoid arthritis. The data aims to illustrate the antibody's capacity to inhibit both pathways in a single therapy, potentially broadening its clinical applications across various autoimmune diseases. Zura Bio also disclosed timelines for Phase 2 trials: systemic sclerosis in Q4 2024 and hidradenitis suppurativa in Q2 2025.

Positive
  • Zura Bio will present data on tibulizumab's (ZB-106) potential for treating Sjogren's syndrome and rheumatoid arthritis at EULAR 2024.
  • The dual-pathway antibody targets IL-17A and BAFF, offering a unique therapeutic approach.
  • Phase 2 trials are scheduled for systemic sclerosis in Q4 2024 and hidradenitis suppurativa in Q2 2025.
  • Potential broad clinical applications of tibulizumab (ZB-106) in various autoimmune diseases.
Negative
  • Zura Bio is still in the clinical-stage, which implies ongoing development costs without revenue from product sales.
  • Phase 2 trial timelines indicate that commercial availability is not imminent, potentially impacting short-term investor returns.
  • No concrete financial data or projections were provided, leaving uncertainty regarding future financial performance.

Novel, dual-pathway antibody targeting IL-17A and BAFF is expected to enter Phase 2 development in systemic sclerosis in Q4 2024 and hidradenitis suppurativa in Q2 2025

HENDERSON, Nev.--(BUSINESS WIRE)-- Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced it will present data from its tibulizumab (ZB-106) program exploring the clinical potential of the dual-pathway antibody in Sjogren's syndrome and rheumatoid arthritis (RA) at EULAR 2024, June 12-15 in Vienna.

“We are excited to present translational data from our tibulizumab (ZB-106) program to help elucidate the potential to inhibit both IL-17A and BAFF in a single antibody therapy,” stated Michael Howell, Ph.D., Chief Scientific Officer and Head of Translational Medicine. “We believe that dual-pathway inhibition may warrant broad clinical exploration and help define the expanding potential of ZB-106 across a portfolio of autoimmune diseases.”

Zura Bio will present results as detailed below. The poster will be available on the Zura Bio website in the News and Events section and archived for at least 30 days following presentation.

Phase 1 Clinical Trial Evaluating the Pharmacokinetics and Pharmacodynamics of a Novel IL-17A and BAFF Dual Antagonist in Sjogren’s Syndrome

Poster 0373
Date: Friday, June 14
Poster Tour: 15:27 – 15:33 CEST / 9:27 – 9:33 ET
Location: Poster Tour 1
Presenter: Dr. Michael Howell, Zura Bio

Abstract is available here on the EULAR 2024 website.

Resolving Inflammation in a Murine Model of Arthritis Through the Dual Antagonism of B-Cell Activating Factor (BAFF) and IL-17

Abstract, accepted for publication only, is available here on the EULAR 2024 website.

ABOUT ZURA BIO

Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies and are Phase 2 ready. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), ZB-168, and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.

FORWARD-LOOKING STATEMENTS

This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding Zura Bio’s anticipated proceeds to be received in the proposed Private Placement, expected timing of closing of the proposed Private Placement and the size, completion and use of proceeds of the proposed Private Placement, the forecast of cash runway and the Company’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives, statements related to Zura Bio’s abilities to achieve anticipated internal readouts and achieve them in expected time periods, Zura Bio’s product candidates, clinical trials and the design and timing thereof, statements with respect to expected therapeutic potential and statements regarding Zura Bio’s product candidates ability to proceed into Phase 2 clinical trials. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability.

Actual events and the ability to consummate the proposed Private Placement and the timing and proceeds thereof; are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of Zura Bio's 10-K for the year ended December 31, 2023 and other filings with the SEC, including: Zura Bio’s expectations regarding product candidates and their related benefits; Zura Bio’s beliefs regarding potential benefits or limitations of competing products both in development and approved; information regarding Zura Bio’s vision and strategy; anticipated timing of key events and initiation of Zura Bio’s studies and release of clinical data; Zura Bio’s expectations regarding the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients; Zura Bio’s ability to attract and retain key personnel; the accuracy of Zura Bio’s future operating expenses, capital requirements and needs for additional financing; Zura Bio’s ability to obtain funding for operations, including funds that may be necessary to complete development of our product candidates; the fact that Zura Bio has not completed any clinical trials and has no products approved for commercial sale; the fact that Zura Bio has incurred significant losses since inception, and it expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio’s ability to renew existing contracts; Zura Bio’s reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio’s ability to obtain regulatory approval for our products, and any related restrictions or limitations of any approved products; Zura Bio’s ability to effectively manage growth and competitive pressures from other companies worldwide in the therapies in which Zura Bio competes; and litigation and Zura Bio’s ability to adequately protect intellectual property rights. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, including projections, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, or should circumstances change, except as otherwise required by securities and other applicable laws.

Megan K. Weinshank

Head of Investor Relations

ir@zurabio.com

Lee M. Stern

Meru Advisors

lstern@meruadvisors.com

Source: Zura Bio Limited

FAQ

What is tibulizumab (ZB-106)?

Tibulizumab (ZB-106) is a dual-pathway antibody developed by Zura Bio, targeting IL-17A and BAFF for treating autoimmune diseases.

When will Zura Bio present the data on tibulizumab (ZB-106)?

Zura Bio will present data on tibulizumab (ZB-106) at EULAR 2024, which takes place from June 12-15 in Vienna.

Which diseases will tibulizumab (ZB-106) target in Phase 2 trials?

Tibulizumab (ZB-106) will target systemic sclerosis in Q4 2024 and hidradenitis suppurativa in Q2 2025 in Phase 2 trials.

What is the significance of targeting both IL-17A and BAFF in tibulizumab (ZB-106)?

Targeting both IL-17A and BAFF aims to offer a comprehensive therapeutic approach, potentially treating a broader range of autoimmune diseases.

Where can I find the abstract for the tibulizumab (ZB-106) presentation?

The abstract for the tibulizumab (ZB-106) presentation will be available on the EULAR 2024 website and the Zura Bio website in the News and Events section.

Zura Bio Limited

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