FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 31 March
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
Friday 31 March 2017, London UK - LSE Announcement
GSK starts phase III study with mepolizumab in patients with severe
hypereosinophilic syndrome
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced the start of a phase III study
with mepolizumab, an interleukin 5 (IL-5) antagonist, in patients
with severe hypereosinophilic syndrome (HES).
The
study, which aims to randomise between 80-120 patients, is
evaluating the effects of mepolizumab compared to placebo when
added to the standard of care. The primary endpoint of the study is
the proportion of patients who experience an HES flare (worsening
of symptoms requiring escalation in therapy) during the 32-week
study treatment period. Secondary endpoints aim to demonstrate
supportive evidence for the benefit of mepolizumab compared with
placebo and include time to first HES flare, the proportion of
patients who experience an HES flare during week 20 through week
32, and fatigue severity.
HES is
a group of inflammatory disorders, affecting approximately 20,000
patients globally, characterised by a persistent and marked
overproduction of a type of white blood cell, known as an
eosinophil. When activated eosinophils from the bloodstream
infiltrate various tissues, they can cause inflammation and organ
damage which, over time, can impact day-to-day function. Depending
on which organs are affected, this can lead to complications
ranging from fever and malaise to blood abnormalities and
respiratory and cardiac problems. If left untreated, the symptoms
of HES become progressively worse and the disease can be
life-threatening.
Steve
Yancey, Vice President and Medicine Development Leader for
mepolizumab, said, "The goal of HES treatment is to prevent
excessive production of eosinophils, reduce or control symptoms and
prevent any further organ damage caused by activated eosinophils.
While limited treatments are available for patients with certain
types of HES, current options for the majority are either
inadequate or come with undesired side-effects associated with
long-term use. The start of our phase III study is an important
development in our work to explore whether mepolizumab could
provide a potential alternative treatment option in this patient
population."
About the phase III study
The pivotal phase III study is
a 32-week, randomised, double-blind, placebo-controlled study to
investigate the efficacy and safety of subcutaneous mepolizumab 300
mg every four weeks compared with placebo in adolescent and adult
patients with severe HES as defined by at least two HES flares
within the past 12 months and a blood eosinophil count of
1000/µL or higher. The results of this study will form the
basis of any regulatory filing plans.
About mepolizumab
Mepolizumab
is a humanised IgG1 monoclonal antibody specific for IL-5. It is
part of the company's respiratory portfolio - one of six core areas
of scientific research and development alongside
immuno-inflammation, oncology, vaccines and infectious and rare
diseases.
IL-5 is
a cytokine which regulates the growth, activation and survival of
eosinophils. It provides an essential signal for the movement of
eosinophils from the bone marrow to the lung and other organs.
Mepolizumab binds to IL-5 and blocks its activity, resulting in a
decrease in eosinophil levels.
Mepolizumab
has been granted orphan drug status for the HES indication by
regulatory authorities in the US and the European Union. It is
approved, under the brand name Nucala,
in the EU, the US and a number of other countries for use as
an add-on treatment for patients with severe asthma, with an
eosinophilic phenotype.
In the US, Nucala (100mg fixed
dose subcutaneous injection of mepolizumab) is licensed as
an add-on maintenance treatment for
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype. Nucala is not approved for the treatment of
other eosinophilic conditions or relief of acute bronchospasm or
status asthmaticus. Full US Prescribing
Information is available at US
Prescribing Information Nucala.
In the EU, Nucala (100mg fixed dose subcutaneous injection of
mepolizumab) is licensed as an add-on treatment for severe
refractory eosinophilic asthma in adult patients.
For
the EU Summary of Product Characteristics for Nucala, please
visit:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003860/WC500198037.pdf
Mepolizumab is also being investigated in chronic obstructive
pulmonary disease (in phase
III), eosinophilic
granulomatosis with polyangitis (EPGA, also referred to as
Churg-Strauss syndrome, in phase
III), nasal polyposis (phase
II) and severe atopic dermatitis (phase I). It is not approved
anywhere in the world for HES.
Nucala®
is a registered trade mark of the GSK
group of companies.
Important Safety Information for Nucala
Please consult the full Prescribing Information for all the
labelled safety information for Nucala.
CONTRAINDICATIONS
Nucala should not be administered to patients with a history of
hypersensitivity to mepolizumab or excipients in the
formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g. anaphylaxis, angioedema,
bronchospasm, hypotension, urticaria, rash) have occurred following
administration of Nucala. These reactions generally occur within
hours of administration but in some instances can have a delayed
onset (i.e. days). In the event of a hypersensitivity reaction,
Nucala should be discontinued.
Acute Asthma Symptoms or Deteriorating
Disease
Nucala should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of
herpes zoster occurred in subjects treated with Nucala compared to
none in placebo. Consider varicella vaccination if medically
appropriate prior to starting therapy with Nucala.
Reduction of Corticosteroid Dosage
Do not
discontinue systemic or inhaled corticosteroids (ICS) abruptly upon
initiation of therapy with Nucala. Decreases in corticosteroid doses,
if appropriate, should be gradual and under the direct supervision
of a physician. Reduction
in corticosteroid dose may be associated with systemic withdrawal
symptoms and/or unmask conditions previously suppressed by systemic
corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if Nucala
will influence a patient's response
against parasites. Treat patients with pre-existing helminth
infections before initiating therapy with Nucala.
If patients become infected while receiving treatment with
Nucala
and do not respond to anti-helminth
treatment, discontinue treatment with Nucala
until infection
resolves.
ADVERSE REACTIONS
The most common adverse reactions (≥3% and more common than
placebo) reported in the first 24 weeks of two clinical trials
with Nucala
(and placebo) were: headache, 19%
(18%); injection site reaction, 8% (3%); back pain, 5% (4%);
fatigue, 5% (4%); influenza, 3% (2%); urinary tract infection 3%
(2%); abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3%
(<1%); and muscle spasm, 3% (<1%).
Systemic Reactions, including Hypersensitivity Reactions: In
3 clinical trials, 3% of subjects who received Nucala
experienced systemic (allergic and
nonallergic) reactions compared to 5% in the placebo group.
Systemic allergic/hypersensitivity reactions were reported by 1% of
subjects who received Nucala
compared to 2% of subjects in the
placebo group. Manifestations included rash, pruritus, headache,
and myalgia. Systemic nonallergic reactions were reported by 2% of
subjects who received Nucala
and 3% of subjects in the placebo
group. Manifestations included rash, flushing, and myalgia. A
majority of the systemic reactions were experienced on the day of
dosing.
Injection site reactions (e.g. pain, erythema, swelling,
itching, burning sensation) occurred at a rate of 8% in
subjects treated with Nucala
compared with 3% in subjects treated
with placebo.
USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in women
exposed to Nucala
during pregnancy. Healthcare
providers can enrol patients or encourage patients to enrol
themselves by calling 1-877-311-8972 or visiting
www.mothertobaby.org/asthma.
The
data on pregnancy exposures from the clinical trials are
insufficient to inform on drug-associated risk. Monoclonal
antibodies, such as mepolizumab, are progressively transported
across the placenta in a linear fashion as pregnancy progresses;
therefore, potential effects on a foetus are likely to be greater
during the second and third trimesters of pregnancy.
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.
GSK enquiries:
|
|
|
|
UK
Media enquiries:
|
Simon
Steel
|
+44 (0)
20 8047 5502
|
(London)
|
|
David
Daley
|
+44 (0)
20 8047 5502
|
(London)
|
|
Namrata
Taak
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
|
|
US Media enquiries:
|
Sarah Alspach
|
+1 202 715 1048
|
(Washington, DC)
|
|
Sarah Spencer
|
+1 215 751 3335
|
(Philadelphia)
|
|
Karen Hagens
|
+1 919 483 2863
|
(North Carolina)
|
|
|
|
|
Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5557
|
(London)
|
|
Tom
Curry
|
+ 1 215
751 5419
|
(Philadelphia)
|
|
Gary
Davies
|
+44 (0)
20 8047 5503
|
(London)
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
|
|
GSK cautionary statement regarding forward-looking
statementsGSK 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 2016.
|
Registered in England & Wales:
No. 3888792
|
|
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: March
31, 2017
|
|
|
|
|
By: VICTORIA
WHYTE
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|