TIDMGSK
RNS Number : 9493X
GlaxoSmithKline PLC
02 May 2019
Issued: 2 May 2019, London UK - LSE Announcement
Phase III CAPTAIN study of Trelegy Ellipta in patients with
asthma meets primary endpoint
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ:
INVA) today announced headline results from the pivotal phase III
CAPTAIN study of once-daily single inhaler triple therapy Trelegy
Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI)
compared to Relvar/Breo Ellipta (FF/VI), in the treatment of
patients living with uncontrolled asthma.
The study met its primary endpoint, demonstrating a
statistically significant 110mL improvement in lung function
(measured by change from baseline in trough FEV(1) at 24 weeks of
treatment) for FF/UMEC/VI 100/62.5/25mcg (p<0.001, 95% CI:
66-153 mL) compared with Relvar/Breo 100/25mcg and a statistically
significant 92mL improvement in trough FEV(1) for FF/UMEC/VI
200/62.5/25mcg versus Relvar/Breo 200/25mcg (p<0.001, 95% CI:
49-135 mL).
The key secondary endpoint was annualised rate of
moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25 and
200/62.5/25) versus Relvar/Breo (100/25 and 200/25) and
demonstrated a 13% (95% CI: -5.2 to 28.1) reduction in
exacerbations, however this was not statistically significant.
Therefore, all subsequent analyses were considered descriptive.
Dr. Hal Barron, Chief Scientific Officer and President, R&D,
GSK, said: "We believe a once-daily single inhaler triple therapy
that improves lung function is an advance for patients with
uncontrolled asthma since this option is not currently available.
We plan to submit these data for regulatory review after the full
dataset is available."
CAPTAIN was also designed to investigate two further doses of
FF/UMEC/VI (100/31.25/25 and 200/31.25/25 mcg) compared to
Relvar/Breo (100/25 and 200/25). There were increases in trough
FEV(1) of a similar magnitude to those of FF/UMEC/VI 100/62.5/25
and 200/62.5/25, with no difference in exacerbation rates.
The safety profile of FF/UMEC/VI was consistent with the known
profile of the individual components and their combinations.
Adverse event rates were similar across all six study arms with the
most common adverse events being reported as nasopharyngitis
(13-15%), headache (5-9%), upper respiratory tract infection (3-6%)
and bronchitis (3-5%).
Dr. Paul Meunier, Vice President of Respiratory Medicine at
Innoviva noted that: "The CAPTAIN study has shown that triple
therapy in a single inhaler provides a potential new treatment
option for asthma management in patients uncontrolled on
ICS/LABA."
Full results from CAPTAIN will be submitted for future
presentation at upcoming scientific meetings and in peer-reviewed
publications.
About CAPTAIN
CAPTAIN (Clinical study of Asthma Patients receiving Triple
therapy through A single INhaler) is a randomised, double-blind,
active controlled, six-arm parallel group, global multicentre study
evaluating FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25 and
200/62.5/25 mcg) versus FF/VI (100/25 and 200/25 mcg) given
once-daily to patients whose asthma is inadequately controlled
despite treatment with ICS/LABA (>250mcg/day fluticasone
propionate, or equivalent) maintenance asthma medication. In the
study 2,436 patients were treated across 15 countries with
approximately 400 patients randomly assigned to each of the six
treatment arms.
CAPTAIN evaluated as its primary endpoint the change from
baseline in trough Forced Expiratory Volume in 1 second (FEV(1) )
at 24 weeks of treatment. The key secondary endpoint was the
annualised rate of moderate/severe asthma exacerbations.
About Trelegy Ellipta (FF/UMEC/VI)
Trelegy Ellipta is a combination of three molecules in a single
inhaler. It contains fluticasone furoate, an inhaled
corticosteroid, umeclidinium, a long-acting muscarinic antagonist;
and vilanterol, a long-acting beta agonist, delivered in GSK's
Ellipta dry powder inhaler. FF/UMEC/VI 100/62.5/25 has been
approved under the brand name Trelegy Ellipta since 2017 for use in
chronic obstructive pulmonary disease (COPD).
Trelegy Ellipta is indicated in the US for the long-term,
once-daily, maintenance treatment of airflow obstruction in
patients with COPD, including chronic bronchitis and/or emphysema.
Trelegy Ellipta is also indicated to reduce exacerbations of COPD
in patients with a history of exacerbations.
Trelegy Ellipta is not approved for the relief of acute
bronchospasm or the treatment of asthma anywhere in the world.
Full US Prescribing Information, including Patient Information
is available at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF
Important Safety Information (ISI)
The following ISI is based on the Highlights section of the US
Prescribing Information for Trelegy Ellipta. Please consult the
full Prescribing Information for all the labelled safety
information.
Trelegy Ellipta is NOT indicated for the relief of acute
bronchospasm or for the treatment of asthma.
Trelegy Ellipta is contraindicated in patients with severe
hypersensitivity to milk proteins or any of the ingredients.
LABA monotherapy increases the risk of serious asthma-related
events.
Trelegy Ellipta should not be initiated in patients experiencing
episodes of acutely deteriorating COPD. Do not use Trelegy Ellipta
to treat acute symptoms.
Trelegy Ellipta should not be used in combination with other
medicines containing LABA because of risk of overdose.
Candida albicans infection of the mouth and pharynx has occurred
in patients treated with fluticasone furoate, a component of
Trelegy Ellipta. Monitor patients periodically. Advise the patient
to rinse his/her mouth with water without swallowing after
inhalation to help reduce the risk.
There is an increased risk of pneumonia in patients with COPD
taking Trelegy Ellipta. Monitor patients for signs and symptoms of
pneumonia.
Patients who use corticosteroids are at risk for potential
worsening of infections (e.g. existing tuberculosis; fungal,
bacterial, viral, or parasitic infections; or ocular herpes
simplex). Use Trelegy Ellipta with caution in patients with these
infections. More serious or even fatal course of chickenpox or
measles can occur in susceptible patients.
There is a risk of impaired adrenal function when transferring
from systemic corticosteroids. Taper patients slowly from systemic
corticosteroids if transferring to Trelegy Ellipta.
Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage of Trelegy Ellipta in susceptible
individuals. If such changes occur, consider appropriate
therapy.
If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta
and institute alternative therapy.
Use Trelegy Ellipta with caution in patients with cardiovascular
disorders because of beta-adrenergic stimulation.
Assess patents for decrease in bone mineral density initially
and periodically thereafter after prescribing Trelegy Ellipta.
Consider referral to an ophthalmologist in patients who develop
ocular symptoms or use Trelegy Ellipta long term. Worsening of
narrow-angle glaucoma may occur. Use with caution in patients with
narrow-angle glaucoma and instruct patients to contact a healthcare
provider immediately if symptoms occur.
Worsening of urinary retention may occur in patients taking
Trelegy Ellipta. Use with caution in patients with prostatic
hyperplasia or bladder-neck obstruction and instruct patients to
contact a healthcare provider immediately if symptoms occur.
Use Trelegy Ellipta with caution in patients with convulsive
disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Be alert to hypokalemia and hyperglycemia in patients taking
Trelegy Ellipta.
The most common adverse reactions reported for Trelegy Ellipta
(incidence >=1%) are upper respiratory tract infection,
pneumonia, bronchitis, oral candidiasis, headache, back pain,
arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia,
constipation, urinary tract infection, diarrhea, gastroenteritis,
oropharyngeal pain, cough, and dysphonia.
About asthma
Asthma is a chronic lung disease that inflames and narrows the
airways. Asthma affects 358 million people worldwide. Despite
medical advances, more than half of patients continue to experience
poor control and significant symptoms. At least 30% of patients
adherent to ICS/LABA therapy remain uncontrolled which can
negatively impact their lives.
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.
GSK's commitment to respiratory disease
For 50 years, GSK has led the way in developing medicines that
advance the management of asthma and COPD. From introducing the
world's first selective short-acting beta agonist in 1969, to
launching six treatments in five years to create today's
industry-leading respiratory portfolio, we continue to innovate so
we can reach the right patients, with the right treatment. Working
together with the healthcare community, we apply world-class
science to discover and understand the molecules that become the
medicines of tomorrow. We won't stand still until the simple act of
breathing is made easier for everyone.
GSK - a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
Trade marks are owned by or licensed to the GSK group of
companies.
Innoviva - Innoviva is focused on royalty management. Innoviva's
portfolio is anchored by the respiratory assets partnered with
Glaxo Group Limited (GSK), including RELVAR(R) /BREO(R) ELLIPTA(R)
, ANORO(R) ELLIPTA(R) and TRELEGY(R) ELLIPTA(R) , which were
jointly developed by Innoviva and GSK. Under the agreement with
GSK, Innoviva is eligible to receive associated royalty revenues
from RELVAR(R) /BREO(R) ELLIPTA(R) and ANORO(R) ELLIPTA(R) . In
addition, Innoviva retains a 15 percent economic interest in future
payments made by GSK for TRELEGY(R) ELLIPTA(R) and earlier-stage
programs partnered with Theravance Biopharma, Inc. For more
information, please visit Innoviva's website at www.inva.com.
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
US Media enquiries: Karen Hagens +1 919 483 2863 (North Carolina)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 8047 (London)
enquiries: 5194
James Dodwell +44 (0) 20 8047 (London)
2406
Danielle Smith +44 (0) 20 8047 (London)
7562
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Innoviva, Inc. enquiries:
Investor and Media: Dan Zacchei / +1 (212) 446 9500 (California)
Alex Kovtun dzacchei@sloanepr.com
/ akovtun@sloaneprr.com
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 Principal risks and uncertainties in the company's Annual
Report on Form 20-F for 2018.
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, 2018, which is on file with the Securities and Exchange
Commission (SEC) and available on the SEC's website at www.sec.gov.
Additional factors may be described in those sections of Innoviva's
Quarterly Report on Form 10-Q for the quarter ended March 31,
2019, to be filed with the SEC in the second quarter of 2018.
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)
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END
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