LONDON & BRISBANE, Calif.--(BUSINESS WIRE)--
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA)
today announced the start of a phase III study investigating the effects
of once-daily closed triple combination therapy fluticasone
furoate/umeclidinium/vilanterol (FF/UMEC/VI) when compared to therapy
with the once-daily dual combination therapy, Relvar/Breo® (FF/VI),
as a treatment for patients with asthma.
The closed triple combination therapy comprises three medicines:
fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a
long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting
beta2-adrenergic agonist (LABA), delivered once-daily in
GSK's Ellipta® dry powder inhaler.
In the phase III study, termed CAPTAIN (Clinical study of Asthma
Patients receiving Triple therapy through A single INhaler), the primary
endpoint is the change from baseline in trough Forced Expiratory volume
in 1 second (FEV1) at 24 weeks of treatment and the key
secondary endpoint is the annualized rate of moderate/severe asthma
exacerbations. Other secondary endpoints are assessing health-related
quality of life and symptom control.
Dave Allen, Head of Respiratory R&D at GSK, said, "Despite the
availability of treatments, many patients have asthma that is
inadequately controlled. While some patients already receive triple
therapy in two or more inhalers, we believe there will be real benefits
from delivering the dual bronchodilators together with their inhaled
steroid once a day in a single inhalation."
Mike Aguiar, CEO of Innoviva, Inc., added, "Closed triple therapy may
provide a new once-a-day treatment option for asthma patients not
adequately controlled by existing therapy. If successful, this would
further expand the portfolio of respiratory therapy products delivered
via the Ellipta inhaler for the treatment of asthma and COPD."
About the phase III study
(Clinical study of Asthma Patients receiving Triple
therapy through A single INhaler) is a superiority study
to demonstrate the add-on benefit of UMEC at two dosage strengths of
62.5 mcg and 31.25 mcg in a single inhaler when compared to FF/VI. It is
a randomized, double-blind, active controlled, six-arm parallel group,
global multicenter study evaluating FF/UMEC/VI (100/31.25/25,
100/62.5/25, 200/31.25/25 and 200/62.5/25 micrograms) versus FF/VI
(100/25 and 200/25 micrograms) given once daily in the morning to
patients whose asthma is inadequately controlled despite treatment with
maintenance asthma medication. The study aims to randomize 2,250
patients, with 375 patients randomly assigned to each of the six
Asthma is a chronic lung disease that inflames and narrows the airways.
Asthma affects 242 million people worldwide. Despite
medical advances, more than half of patients continue to experience poor
control and significant symptoms.
The causes of asthma are not completely understood but likely involve an
interaction between a person's genetic make-up and the environment. Key
risk factors are inhaled substances that provoke allergic reactions or
irritate the airways.
Ellipta® (fluticasone furoate + vilanterol)
Relvar/Breo Ellipta is a once-daily dual combination treatment
comprising fluticasone furoate, an inhaled corticosteroid and
vilanterol, a long-acting beta2-agonist, in a single inhaler,
the Ellipta®. Full US prescribing information, including
BOXED WARNING and Medication Guide is available at us.gsk.com or US
Prescribing Information for Breo Ellipta, EU
Prescribing Information for Relvar Ellipta.
Innoviva - Innoviva is focused on bringing compelling new
medicines to patients in areas of unmet need by leveraging its
significant expertise in the development, commercialization and
financial management of bio-pharmaceuticals. Innoviva's portfolio is
anchored by the respiratory assets partnered with Glaxo Group Limited
(GSK), including RELVAR®/BREO®
ELLIPTA® and ANORO® ELLIPTA®,
which were jointly developed by Innoviva and GSK. Under the agreement
with GSK, Innoviva is eligible to receive associated royalty revenues
from RELVAR®/BREO® ELLIPTA®,
ANORO® ELLIPTA®. In addition,
Innoviva retains a 15 percent economic interest in future payments made
by GSK for earlier-stage programs partnered with Theravance Biopharma,
Inc., including the closed triple combination therapy for COPD. For more
information, please visit Innoviva's website at www.inva.com.
GSK - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality of
human life by enabling people to do more, feel better and live longer.
For further information please visit www.gsk.com.
RELVAR®, BREO® and ELLIPTA® are
trademarks of the GlaxoSmithKline group of companies.
GSK cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to
differ materially from those projected. Such factors include, but are
not limited to, those described under Item 3.D ‘Risk factors' in the
company's Annual Report on Form 20-F for 2015.
Innoviva 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 and future events, including the development, regulatory and
commercial plans for closed triple combination therapy and the potential
benefits and mechanisms of action of closed triple combination therapy.
Innoviva 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. Such forward-looking
statements involve substantial risks, uncertainties and assumptions.
These statements are based on the current estimates and assumptions of
the management of Innoviva as of the date of this press release and are
subject to risks, uncertainties, changes in circumstances, assumptions
and other factors that may cause the actual results of Innoviva 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 are
described under the headings "Risk Factors" and "Management's Discussion
and Analysis of Financial Condition and Results of Operations" contained
in Innoviva's Annual Report on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended September
30, 2016, which are on file with the Securities and Exchange Commission
(SEC) and available on the SEC's website at www.sec.gov.
In addition to the risks described above and in Innoviva's other filings
with the SEC, other unknown or unpredictable factors also could affect
Innoviva'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. The information in this press release is
provided only as of the date hereof, and Innoviva assumes no obligation
to update its forward-looking statements on account of new information,
future events or otherwise, except as required by law. (INVA-G).
Registered in England & Wales:
980 Great West Road
View source version on businesswire.com: http://www.businesswire.com/news/home/20161219005247/en/
UK Media enquiries:
Simon Steel, +44 (0)
20 8047 5502 (London)
David Daley, +44 (0) 20 8047 5502 (London)
Macleod, +44 (0) 20 8047 5502 (London)
US Media enquiries:
Alspach, +1-202-715-1048 (Washington, DC)
Karen Hagens, +1-919-483-2863 (North
Tom Curry, +
Gary Davies, +44 (0) 20 8047 5503
James Dodwell, +44 (0) 20 8047 2406 (London)
McLaughlin, +1-215-751-7002 (Philadelphia)
+1-650-238-9605 (Brisbane, Calif.)
Source: Innoviva, Inc.
News Provided by Acquire Media