- TibuSURE is the first clinical trial designed to investigate
anti-BAFF and IL-17 pathways in systemic sclerosis.
- TibuSURE launches with the initiation of its first clinical
site.
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.
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the full release here:
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Phase 2 TibuSURE study will evaluate
tibulizumab in adults with systemic sclerosis (SSc). (Graphic:
Business Wire)
"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.”
ABOUT TibuSURE
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 organ systems.
ABOUT TIBULIZUMAB
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.
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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241223167603/en/
Megan K. Weinshank Head of Corporate Affairs ir@zurabio.com
Zura Bio (NASDAQ:ZURA)
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