- Randomized, double-blind, placebo-controlled study
did not meet the primary endpoint: improvement in OHSA #1 in
patients receiving ampreloxetine for four weeks compared to
placebo
DUBLIN and SOUTH SAN
FRANCISCO, Calif., Sept, 15, 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 a
Phase 3 randomized, double-blind, placebo-controlled multi-center
Phase 3 study assessing the safety and efficacy of ampreloxetine
compared to placebo for the treatment of symptomatic neurogenic
orthostatic hypotension (nOH).
The study did not meet its primary endpoint. The majority of
treatment-related adverse events were mild or moderate in severity.
Serious adverse events occurred in two patients on placebo and four
on ampreloxetine and none were considered related to the study
drug; no deaths were reported. There was no signal for supine
hypertension. The Company plans to present the results at a future
scientific forum.
"These are not the results we had hoped to achieve,
especially given the clear unmet need for patients suffering from
symptomatic nOH and the positive top-line four-week results from
the Phase 2 study announced in 2018. We will continue to analyze
the data to better understand the findings," said Rick E
Winningham, Chief Executive Officer, Theravance Biopharma. "We
are grateful to all those who dedicated their time and efforts to
progress this study, especially during the challenges of the
pandemic. We are hopeful that insights from this study may inform
future drug development to help those with this debilitating
condition."
In light of these results, the Company will be determining the
appropriate next steps for Study 0170 (NCT03829657; more than 75%
enrolled) and Study 0171 (NCT04095793); clinical trial sites will
be notified accordingly.
About the Phase 3 Study
Study 0169 (NCT03750552) was a Phase 3, 4-week, randomized,
double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy and safety of ampreloxetine compared to placebo in
patients with symptomatic nOH (n=195). Patients from Study 0169
were eligible to enter into Study 0170, a Phase 3, 22-week,
multi-center, randomized withdrawal study to evaluate the sustained
benefit in efficacy and safety of ampreloxetine in patients with
symptomatic nOH.
About Symptomatic nOH
Neurogenic orthostatic hypotension (nOH) is a rare disorder
defined as a sustained orthostatic fall in systolic blood pressure
(SBP) of ≥ 20 mm Hg or diastolic blood pressure (DBP) of ≥ 10 mm Hg
within three minutes of standing. Severely affected patients are
unable to stand for more than a few seconds because of their
decrease in blood pressure, leading to cerebral hypoperfusion and
syncope. A debilitating condition, nOH results in a range of
symptoms including dizziness, lightheadedness, fainting, fatigue,
blurry vision, weakness, trouble concentrating, and head and neck
pain. nOH is caused by autonomic nervous system malfunction and is
associated with several underlying medical conditions including
multiple system atrophy (MSA), pure autonomic failure (PAF), and
Parkinson's disease (PD).
About OHSA #1
OHSA #1 is an endpoint that is part of the Orthostatic
Hypotension Questionnaire, a validated scale assessing the presence
of a range of hypotension-related symptoms including dizziness,
weakness, problems with vision, fatigue, trouble concentrating, and
head/neck discomfort. It is based on a scale from 0 (no symptoms)
to 10 (worst possible severity of a symptom), with reductions in
OHSA points indicating symptom improvement and increases in OHSA
score indicating symptom worsening. OHSA #1 specifically measures
patients' dizziness, lightheadedness, feeling faint, or feeling
like they might black out. OHSA #1 has been accepted as a suitable
endpoint in the investigation of neurogenic orthostatic hypotension
by regulatory agencies.
About Ampreloxetine
Ampreloxetine (TD-9855) is an investigational, Theravance
Biopharma-discovered, potent, long-acting, once-daily
norepinephrine reuptake inhibitor in development for the treatment
of symptomatic neurogenic orthostatic hypotension (nOH).
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 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
potential characteristics, benefits and mechanisms of action of the
Company's product and product candidates, and interpretation of the
results of our clinical trials or conclusions drawn therefrom.
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: 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, and additional future analysis of the data
resulting from our clinical trial(s). 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
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