DUBLIN and SOUTH SAN FRANCISCO, Calif., Aug. 23, 2021 /PRNewswire/ -- Theravance
Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:
TBPH), a diversified biopharmaceutical company primarily focused on
the discovery, development, and commercialization of
organ-selective medicines, today announced top-line results from
its Phase 2b dose-finding induction
study of izencitinib, an orally administered, gut-selective
pan-Janus kinase (JAK) inhibitor in development for the treatment
of ulcerative colitis.
The study did not meet its primary endpoint of change in the
total Mayo score or the key secondary endpoint of clinical
remission at week 8, relative to placebo. There was a small
dose-dependent increase in clinical response measured by the
adapted Mayo score, which was driven by a reduction in rectal
bleeding.
At all doses, izencitinib was well-tolerated when administered
orally once daily for 8 weeks; adverse event rates were similar
among patients receiving izencitinib and placebo. There were no
instances of perforation, opportunistic infection, major
cardiovascular or thromboembolic event, complicated zoster, or
non-melanoma skin cancer in patients receiving izencitinib. There
were no notable changes in lab values including creatine
phosphokinase and lipids in patients receiving izencitinib relative
to placebo. Plasma exposure of izencitinib was low, consistent with
expectations for a gut-selective medicine.
The Company plans to present study results at a scientific
forum.
"We had high expectations for the Phase 2b study after eight weeks of treatment with
izencitinib in ulcerative colitis given the totality and
consistency of the broad range of clinical, histologic, and
biomarker data we saw in the Phase 1b
study with only four weeks of treatment, albeit in a small number
of patients. We plan to analyze the data to better understand the
findings and the potential for optimization of a gut-selective
medicine as a treatment for patients
with inflammatory bowel diseases," said Rick E
Winningham, Chief Executive Officer, Theravance Biopharma. "We are
grateful to all those who participated in this clinical trial and
to those who are still participating in the Crohn's Phase 2
study – which we expect to report top-line
results in late fourth quarter 2021 or early first
quarter 2022."
Regarding current plans, the Company will work to understand the
complete results and implications for izencitinib. Forthcoming
ulcerative colitis data will include results from the 16-week
extended induction portion of the study and the 44-week maintenance
study. The Company reiterates timing of the top-line results of the
Crohn's Phase 2 study in late fourth quarter 2021 or early first
quarter 2022. Based on the ulcerative colitis results, the Company
will seek to minimize future expenses associated with the
izencitinib program.
Conference Call and Live Webcast Today at 5 pm ET
Theravance Biopharma will hold a conference call and live
webcast accompanied by slides today at 5 pm
ET / 2 pm PT / 10 pm IST. To participate, please dial (855)
296-9648 from the U.S. or (920) 663-6266 for
international callers, using the confirmation code 3198387. Those
interested in listening to the conference call live via the
internet may do so by visiting Theravance.com, under the Investors
section, Events and Presentations.
A replay will be available on Theravance.com under the Investors
section for 30 days. An audio replay will be also available through
8:00 p.m. ET on August 30, 2021, by dialing (855) 859-2056 from
the U.S., or (404) 537-3406 for international callers, and then
entering confirmation code 3198387.
About the Phase 2b Dose-Finding
Induction Study
The study was a randomized, double-blind, placebo-controlled,
multi-center Phase 2b dose-finding
induction study (NCT03758443) for the treatment of adults with
moderately-to-severely active ulcerative colitis with the
primary endpoint at Week 8 (n=239). The safety and efficacy data of
this Phase 2b study were intended to
inform induction and maintenance dose regimens for a confirmatory
Phase 3 induction study and the ongoing maintenance study.
About Theravance Biopharma and Janssen Strategic
Collaboration
Theravance Biopharma and Janssen Biotech, Inc. have a global
co-development and commercialization agreement
for izencitinib, also known as TD-1473, and other
compounds for inflammatory intestinal diseases. Under the terms of
the agreement, Theravance Biopharma received an upfront payment of
$100 million and is eligible to
receive up to an additional $900
million in potential payments, if Janssen elects to remain
in the collaboration following the completion of certain Phase 2
activities. In that scenario, Theravance Biopharma and
Janssen will jointly develop and
commercialize izencitinib in inflammatory intestinal
diseases, with the two companies sharing expenses related to a
potential Phase 3 program and profits in the
U.S.
About Janus (JAK) Kinase Inhibition
JAK inhibitors function by inhibiting the activity of one or
more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2)
that play a key role in cytokine signaling. Inhibiting these JAK
enzymes interferes with the JAK/STAT signaling pathway and, in
turn, modulates the activity of a wide range of pro-inflammatory
cytokines. JAK inhibitors are currently approved for the treatment
of immune-mediated diseases such as rheumatoid arthritis,
myelofibrosis, and ulcerative colitis. However, these products are
known to have adverse effects associated with their systemic
exposure.
About Izencitinib
Izencitinib, also known as TD-1473, is an orally
administered, once-daily, investigational, internally discovered,
high affinity, reversible pan-JAK inhibitor which was designed to
be gut selective. The gut-selective design provides izencitinib the
potential to distribute throughout the gastrointestinal tract
tissues and target inflammation at the site of
gastrointestinal disease while limiting its systemic exposure.
Theravance Biopharma is focused on utilizing izencitinib
for the potential treatment of a range of inflammatory
intestinal diseases including ulcerative colitis and Crohn's
disease.
About Theravance Biopharma
Theravance Biopharma, Inc. is a diversified biopharmaceutical
company primarily focused on the discovery, development and
commercialization of organ-selective medicines. Its purpose is to
pioneer a new generation of small molecule drugs designed to better
meet patient needs. Its research is focused in the areas of
inflammation and immunology.
In pursuit of its purpose, Theravance Biopharma applies insights
and innovation at each stage of its business and utilizes its
internal capabilities and those of partners around the world. The
Company applies organ-selective expertise to target disease
biologically, to discover and develop medicines that may expand the
therapeutic index with the goal of maximizing efficacy and limiting
systemic side effects. These efforts leverage years of experience
in developing lung-selective medicines to treat respiratory
disease, including FDA-approved YUPELRI® (revefenacin)
inhalation solution indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD). Its
pipeline of internally discovered programs is targeted to address
significant patient needs.
Theravance Biopharma has an economic interest in potential
future payments from Glaxo Group Limited or one of its affiliates
(GSK) pursuant to its agreements with Innoviva, Inc. relating to
certain programs, including TRELEGY.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and
the Cross/Star logo are registered trademarks of the Theravance
Biopharma group of companies (in the U.S. and certain other
countries).
YUPELRI® is a registered trademark of Mylan Specialty
L.P., a Viatris Company. Trademarks, trade names or service marks
of other companies appearing on this press release are the property
of their respective owners.
Forward-Looking Statements
This press release contains and the conference call will contain
certain "forward-looking" statements as that term is defined in the
Private Securities Litigation Reform Act of 1995 regarding, among
other things, statements relating to goals, plans, objectives,
expectations and future events. Theravance Biopharma intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to: the Company's goals, designs, strategies,
plans and objectives, the Company's regulatory strategies and
timing of clinical studies (including the data therefrom), the
potential characteristics, benefits and mechanisms of action of the
Company's product and product candidates, the potential that the
Company's research programs will progress product candidates into
the clinic, the Company's expectations for product candidates
through development, the Company's expectations regarding its
allocation of resources, potential regulatory approval and
commercialization (including their differentiation from other
products or potential products), product sales or profit share
revenue and the Company's expectations for its expenses, excluding
share-based compensation and other financial results. These
statements are based on the current estimates and assumptions of
the management of Theravance Biopharma as of the date of the press
release and the conference call and are subject to risks,
uncertainties, changes in circumstances, assumptions and other
factors that may cause the actual results of Theravance Biopharma
to be materially different from those reflected in the
forward-looking statements. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, among others, risks related to:
disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of
arbitration and litigation and the possibility that the results of
these proceedings could be adverse to the Company, additional
future analysis of the data resulting from our clinical trial(s),
delays or difficulties in commencing, enrolling or completing
clinical studies, the potential that results from clinical or
non-clinical studies indicate the Company's compounds or product
candidates are unsafe, ineffective or not differentiated,
risks that product candidates do not obtain approval from
regulatory authorities, the feasibility of undertaking future
clinical trials for our product candidates based on policies and
feedback from regulatory authorities, dependence on third parties
to conduct clinical studies, delays or failure to achieve and
maintain regulatory approvals for product candidates, risks of
collaborating with or relying on third parties to discover,
develop, manufacture and commercialize products, and risks
associated with establishing and maintaining sales, marketing and
distribution capabilities with appropriate technical expertise and
supporting infrastructure. In addition, while we expect the effects
of COVID-19 to continue to adversely impact our business operations
and financial results, the extent of the impact on our ability to
generate revenue from YUPELRI® (revefenacin), our clinical
development programs (including but not limited to our later stage
clinical programs for izencitinib and ampreloxetine), and the value
of and market for our ordinary shares, will depend on future
developments that are highly uncertain and cannot be predicted with
confidence at this time. These potential future developments
include, but are not limited to, the ultimate duration of the
COVID-19 pandemic, travel restrictions, quarantines, social
distancing and business closure requirements in the United States and in other countries,
other measures taken by us and those we work with to help protect
individuals from contracting COVID-19, and the effectiveness of
actions taken globally to contain and treat the disease, including
vaccine availability, distribution, acceptance and effectiveness.
Other risks affecting Theravance Biopharma are in the Company's
Form 10-Q filed with the SEC on August 5,
2021 and other periodic reports filed with the SEC. In
addition to the risks described above and in Theravance Biopharma's
filings with the SEC, other unknown or unpredictable factors also
could affect Theravance Biopharma's results. No forward-looking
statements can be guaranteed, and actual results may differ
materially from such statements. Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. Theravance Biopharma assumes no obligation to update
its forward-looking statements on account of new information,
future events or otherwise, except as required by law.
Contact: Gail B. Cohen
Corporate Communications
917-214-6603
View original content to download
multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-inc-announces-top-line-results-from-phase-2b-dose-finding-induction-study-of-izencitinib-in-patients-with-ulcerative-colitis-301360836.html
SOURCE Theravance Biopharma, Inc.