DUBLIN, Feb. 17, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the
"Company") today announced the presentation of positive clinical
data for TD-1473, a novel, potent, and orally administered
pan-Janus kinase (JAK) inhibitor designed to be intestinally
restricted, at the 12th Congress of the European Crohn's
and Colitis Organization (ECCO). In a poster presentation, the
Company reported further data from its completed Phase 1 study of
single-ascending and multiple-ascending doses of TD-1473. Results
of the study were first announced in June
2016. Theravance Biopharma is developing TD-1473 as an
investigational compound with the potential to treat a range of
inflammatory intestinal diseases and is currently conducting a
Phase 1b study of the compound in patients with moderate to severe
ulcerative colitis. The 12th Congress of ECCO is being
held in Barcelona, Spain,
February 15-18, 2017.
The findings presented at ECCO reaffirm previously announced
results from the Phase 1 study which demonstrated TD-1473 to be
generally well tolerated as a single dose (up to 1000 mg) and as a
daily dose (up to 300 mg) given for 14 days. Newly presented data
demonstrated that no moderate, severe or serious treatment emergent
adverse events (TEAEs) were reported in subjects dosed with
TD-1473, and no TEAEs of any severity led to study discontinuation.
TEAEs were higher in subjects receiving placebo than in subjects
receiving TD-1473 in both the single-ascending and
multiple-ascending dose portions of the study.
Additionally, the study data presented demonstrated that TD-1473
exhibited a pharmacokinetic (PK) profile consistent with the
Company's goal of designing the compound to penetrate the
intestinal wall from within and act directly at the site of
inflammation with minimal systemic exposure. Across a range of
doses, the observed systemic concentrations of TD-1473 were
consistent with low bioavailability and intestinal restriction. For
all doses in both the single-ascending and multiple-ascending
groups, the amount of TD-1473 that was excreted in the urine was
less than 0.5% of the administered dose. TD-1473 is designed to be
intestinally restricted, which potentially represents a key
competitive advantage for the compound based on the range of safety
and tolerability concerns associated with systemically available
JAK inhibitors.
"The latest data presented at ECCO align with and build upon the
top-line results from the study. We believe that the totality of
the data generated in the program to date strongly suggests that a
therapeutically relevant level of TD-1473 can be delivered to and
penetrate the colon wall from within with minimal release into the
systemic circulation," said Brett
Haumann, MD, Chief Medical Officer at Theravance Biopharma.
"We are currently conducting a Phase 1b trial of TD-1473 designed
to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of TD-1473 in patients with moderate to severe
ulcerative colitis over 28 days, as well as to measure the drug
levels in the blood following oral administration. This trial will
also provide the first indication of the early effect of TD-1473 on
a range of relevant ulcerative colitis biomarkers, histological
improvements and measures of endoscopic and clinical improvement."
The Company's ongoing Phase 1b trial is a randomized,
double-blind, study in patients with moderate to severe ulcerative
colitis. Forty patients are being randomized to receive one of
three doses of TD-1473 or placebo for 28 days in sequential
fashion. The primary objectives of the study include evaluation of
the safety and tolerability of TD-1473 administered for 28 days, as
well as assessment of the compound's plasma exposure following
administration. A key secondary objective of the trial is the
evaluation of the effect of TD-1473 on levels of a range of key
ulcerative colitis biomarkers, including C-reactive protein (CRP)
and fecal calprotectin (FC). Additionally, investigators will
evaluate several exploratory objectives, including changes in
partial Mayo score and improvement in disease activity through
endoscopic and histologic assessments. The Company expects data
from the Phase 1b trial in mid-2017.
About Intestinally Restricted Pan-Janus Kinase
(JAK) 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 rheumatoid arthritis and myelofibrosis, and have demonstrated
therapeutic benefit for patients with ulcerative colitis. However,
these products are known to have side effects associated with
systemic exposure.
TD-1473 is an internally-discovered JAK inhibitor that has
demonstrated a high affinity for each of the JAK family of enzymes.
Importantly, TD-1473 is designed to be an intestinally restricted
treatment that distributes adequately and predominantly to the
tissues of the intestinal tract, treating inflammation in those
tissues while minimizing systemic exposure. Theravance Biopharma is
focused on utilizing targeted JAK inhibitors for potential
treatment of a range of inflammatory intestinal diseases including
ulcerative colitis, which affects roughly 700,000 patients in the
United States.
About Theravance Biopharma
Theravance Biopharma is a diversified biopharmaceutical company
with the core purpose of creating medicines that help improve lives
of patients suffering from serious illness. Our pipeline of
internally discovered product candidates includes potential
best-in-class medicines to address the unmet needs of patients
being treated for serious conditions primarily in the acute care
setting. VIBATIV® (telavancin), our first commercial
product, is a once-daily dual-mechanism antibiotic approved in the
U.S., Europe and certain other
countries for certain difficult-to-treat infections. Revefenacin
(TD-4208) is a long-acting muscarinic antagonist (LAMA) being
developed as a potential once-daily, nebulized treatment for
chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP)
inhibitor program is designed to develop selective NEP inhibitors
for the treatment of a range of major cardiovascular and renal
diseases, including acute and chronic heart failure, hypertension
and chronic kidney diseases such as diabetic nephropathy. Our
research efforts are focused in the areas of inflammation and
immunology, with the goal of designing medicines that provide
targeted drug delivery to tissues in the lung and gastrointestinal
tract in order to maximize patient benefit and minimize risk. The
first program to emerge from this research is designed to develop
intestinally restricted pan-Janus kinase (JAK) inhibitors for the
treatment of a range of inflammatory intestinal diseases.
In addition, we have an economic interest in future payments
that may be made by Glaxo Group Limited or one of its affiliates
pursuant to its agreements with Innoviva, Inc. relating to certain
drug development programs, including the Closed Triple (the
combination of fluticasone furoate, umeclidinium, and vilanterol),
currently in development for the treatment of COPD and asthma.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and
VIBATIV® are registered trademarks of the Theravance
Biopharma group of companies.
This press release contains 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 strategies, plans and
objectives, the Company's regulatory strategies and timing and
results of clinical studies, the potential benefits and mechanisms
of action of the Company's product and product candidates and the
Company's expectations for product candidates through development,
potential regulatory approval and commercialization. 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 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: delays or difficulties in commencing or
completing clinical studies, the potential that results from
clinical or non-clinical studies indicate the Company's product
candidates are unsafe or ineffective, the feasibility of
undertaking future clinical trials for our product candidates based
on FDA policies and feedback, 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 and
commercialize products, risks associated with establishing and
maintaining sales, marketing and distribution capabilities with
appropriate technical expertise and supporting infrastructure.
Other risks affecting Theravance Biopharma are described under the
heading "Risk Factors" contained in Theravance Biopharma's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 9,
2016. In addition to the risks described above and in
Theravance Biopharma's other 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 Information:
Renee Gala
Chief Financial Officer
650-808-4045
investor.relations@theravance.com
Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com
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SOURCE Theravance Biopharma, Inc.