Full Press Release Details
Zura Bio Launches Global Phase 2 TibuSURE Study
to Evaluate Tibulizumab in Adults with Systemic Sclerosis
HENDERSON, Nev. - (BUSINESS WIRE) -
December 23, 2024 - Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio"), a clinical
stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced
the launch of TibuSURE, a Phase 2 global study evaluating tibulizumab for the treatment of systemic sclerosis (SSc) in adults.
"Single-pathway inhibition has demonstrated
modest effects in rheumatic diseases like SSc. This is why we believe tibulizumab's dual-pathway approach holds the potential to be best-in-class,
aiming to provide deeper efficacy and greater benefits for patients affected by this life-threatening autoimmune disease," said
Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. "The initiation of the TibuSURE study marks
a significant milestone in addressing certain urgent, unmet needs of this patient population and advancing our mission to improve the
lives of those affected by autoimmune and inflammatory conditions."
"Systemic sclerosis is a heterogeneous and
complex autoimmune disease characterized by both inflammatory and fibrotic processes, for which effective therapies remain limited,"
said Christopher Denton, PhD, FRCP, FMedSci, Professor of Experimental Rheumatology at the University College London and Consultant Rheumatologist
and Head of the Centre for Rheumatology at the Royal Free Hospital, London. "Tibulizumab's dual-targeting mechanism offers
a novel strategy by concurrently targeting two pivotal pathways involved in inflammation and fibrosis. This mechanism holds the potential
to address the multi-organ pathology of SSc and help improve the lives of patients with SSc."
TibuSURE is a global Phase 2 double-blind, placebo-controlled study
evaluating the safety, tolerability, and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic
sclerosis (dcSSc). The study includes a 24-week efficacy period and a 28-week open-label extension (OLE). The primary endpoint is the
modified Rodnan Skin Score (mRSS), with key efficacy endpoints including lung disease assessed by quantitative high-resolution computed
tomography (qHRCT) and forced vital capacity (FVC), physical function measured by the Health Assessment Questionnaire-Disability Index
(HAQ-DI), and the revised Combined Response Index in Systemic Sclerosis (rCRISS).
ABOUT SYSTEMIC SCLEROSIS
Systemic sclerosis (SSc), also known as scleroderma,
is a rare, life-threatening autoimmune disease affecting approximately 300,000 individuals worldwide, including around 100,000 in the
United States. Characterized by chronic inflammation and progressive fibrosis of connective tissues, SSc primarily affects the skin and
lungs but can also impact the heart, liver, kidneys, digestive tract, and vascular system. The most common symptoms of SSc include skin
thickening and extreme sensitivity to cold in the extremities. The disease can also affect other organs and tissues, leading to muscle
numbness and swelling, joint stiffness and reduced mobility, fibrosis in the lungs and heart, kidney dysfunction, and gastrointestinal
issues such as difficulty swallowing, heartburn, bloating, constipation, and diarrhea.
There remains a high unmet medical need due to
the limited treatment options available for individuals living with SSc. Currently, only two disease-modifying therapies are FDA-approved
for severe lung complications of the disease (i.e., SSc-ILD), and no effective treatment exists that addresses the disease across multiple
Tibulizumab, an investigational humanized, tetravalent
bispecific dual-antagonist antibody, is a fusion of Taltz (ixekizumab) and tabalumab, engineered to bind to and neutralize both IL-17A
and BAFF. Tibulizumab is currently being evaluated in a Phase 2 study in adults with systemic sclerosis and is expected to enter Phase
2 clinical development for the treatment of hidradenitis suppurativa in Q2 2025. Before in-licensing, Phase 1/1b studies of tibulizumab
were conducted in Sj gren's syndrome and rheumatoid arthritis. Tibulizumab is an investigational compound that is not approved
for marketing by the FDA or any other regulatory authority.
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. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), crebankitug
(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," "goal," "mission," 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: the potential of tibulizumab's dual-pathway approach to be best-in-class and to provide deeper efficacy and greater benefits
for patients affected by SSc; the ability of tibulizumab to address certain unmet needs and improve the lives of patients with SSc; and
expectations with respect to Zura Bio's development program, including regulatory matters, clinical trials and the design and timing
thereof. 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 are difficult or impossible to predict
and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties,
which include, but are not limited to: Zura Bio's expectations regarding its product candidates and their related benefits, and
Zura Bio's beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura
Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and
release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance
of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to
attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs
for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial
sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and
may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations,
and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate
one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter
into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials;
Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies
and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions
or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions;
Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may
be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura
Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors"
section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2023 and other filings with the SEC. 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, 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 update any forward-looking statements, except as required by law.
Head of Corporate Affairs