DUBLIN, April 10,
2024 /PRNewswire/ -- Theravance Biopharma, Inc. (the
"Company") (NASDAQ: TBPH) today announced it will host a virtual
KOL event on Thursday, May 23, 2024
from 10:00 AM to 11:30 AM ET,
featuring Horacio Kaufmann, MD, FAAN
(Felicia B. Axelrod Professor of Neurology and Professor of
Medicine at New York University
Grossman School of Medicine) and Italo Biaggioni, MD (Professor of
Medicine and Pharmacology Director, Vanderbilt Autonomic
Dysfunction Center), who will discuss the unmet need and current
treatment landscape for MSA patients with symptomatic nOH. To
register, click here.
The event will also feature presentations from the Company's
CEO, Rick Winningham, Senior VP of
Development, Aine Miller, and Chief
Business Officer, Rhonda Farnum and
will focus on the Company's clinical development program for
ampreloxetine, an investigational, once-daily norepinephrine
reuptake inhibitor with the potential to be a first-in-class
therapy effective in treating a constellation of cardinal symptoms
of nOH in MSA patients.
A live question and answer session will follow the formal
presentations.
About Horacio Kaufmann, MD,
FAAN
Dr. Kaufmann is the Axelrod Professor of Neurology, Professor of
Medicine and Professor of Pediatrics and Chief of the Division of
Autonomic Disorders, all at New York
University Grossman School of Medicine. He is also the
Director of the Dysautonomia Center at NYU Langone Health.
Dr. Kaufmann's clinical and research careers have been focused
on genetic and neurodegenerative disorders affecting autonomic
neurons, with particular emphasis on the synucleinopathies,
including Pure Autonomic Failure, Parkinson disease and multiple
system atrophy (MSA). He was the PI of the Natural History Study
of the Synucleinopathies (NHSS), a multicenter prospective
study running for ten years funded by the NINDS. Dr. Kaufmann has
established an international collaboration of 22 centers in
America, Europe and Asia that shares data and research projects
and supports the careers of young clinical scientists. He was
co-chair of the task force of the Movement Disorders Society to
update the diagnostic criteria of MSA. He is currently the PI of
the NINDS funded Clinical Trial Readiness in MSA, an international,
multicenter, prospective, observational study to develop a novel
clinical outcome assessment and biomarkers for MSA. He has
published extensively in top tier academic journals as well as
numerous book chapters and consensus criteria.
Dr. Kaufmann has experience designing and conducting phase 1 and
large international phase 3 clinical trials for rare diseases. He
supervises an active clinical service and teaches autonomic
neuroscience to residents and fellows. He is the Editor in
Chief of Clinical Autonomic Research, the preeminent
subspecialty journal published by Springer-Nature.
About Italo Biaggioni, MD
Dr. Biaggioni has over 35 years of experience investigating the
interaction between neural (autonomic) metabolic
(renin-angiotensin, insulin, incretins) and local (adenosine,
nitric oxide) mechanisms involved in cardiovascular regulation. In
particular, he is interested in how these interactions participate
in the pathophysiology of autonomic disorders. He directs the
Vanderbilt Autonomic Dysfunction Center, a multidisciplinary
program dedicated to the evaluation and treatment of patients with
autonomic disorders that includes neurologists, cardiologists,
geriatricians, and clinical pharmacologists. He leads an active
research program, with continued NIH funding for over 30 years that
has resulted in over 350 peer-reviewed publications. The focus of
this research program is to apply clinical research to the
development of novel treatment strategies for autonomic disorders.
His group has participated in the discovery of new autonomic
diseases, and in the development of novel devices, medications, and
repurposing of approved drugs for the treatment of patients with
autonomic disorders.
About Ampreloxetine
Ampreloxetine is an investigational, once-daily norepinephrine
reuptake inhibitor in development for the treatment of symptomatic
nOH in patients with MSA. The unique benefits of ampreloxetine
treatment reported in MSA patients from Study 0170 included an
increase in norepinephrine levels, a favorable impact on blood
pressure, clinically meaningful and durable symptom improvement,
and no signal for supine hypertension. In the US, the Company has
been granted an Orphan Drug Designation for ampreloxetine for the
treatment of symptomatic nOH in patients with MSA and, if results
from the ongoing Phase 3 CYPRESS study are supportive, plans to
file an NDA for full approval in this indication.
About Multiple System Atrophy (MSA) and Symptomatic
Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and
balance and disrupts the function of the autonomic nervous system.
The autonomic nervous system controls body functions that are
mostly involuntary. One of the most frequent autonomic symptoms
associated with MSA is a sudden drop in blood pressure upon
standing (nOH).1 There are approximately 50,000 MSA
patients in the US2 and 70-90% of MSA patients
experience nOH symptoms.3 Despite available
therapies, many MSA patients remain symptomatic with nOH.
Neurogenic orthostatic hypotension (nOH) is a rare disorder
defined as a fall in systolic blood pressure of ⩾20 mm Hg or
diastolic blood pressure of ⩾10 mm Hg, within 3 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.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver Medicines that
Make a Difference® in people's lives. In pursuit of its
purpose, the Company leverages decades of expertise, which has led
to the development of FDA-approved YUPELRI®
(revefenacin) inhalation solution indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD). Ampreloxetine, its late-stage investigational
norepinephrine reuptake inhibitor in development for symptomatic
neurogenic orthostatic hypotension, has the potential to be a first
in class therapy effective in treating a constellation of cardinal
symptoms in multiple system atrophy patients. The Company is
committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and
the Cross/Star logo are registered trademarks of the Theravance
Biopharma, Inc. 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.
Contact:
investor.relations@theravance.com
650-808-4045
1 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
2 UCSD Neurological Institute (25K-75K, with ~10K
new cases per year); NIH National Institute of Neurological
Disorders and Stroke (15K-50K).
3 Delveinsight MSA Market Forecast (2023); Symptoms
associated with orthostatic hypotension in pure autonomic failure
and multiple systems atrophy, CJ Mathias (1999).
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