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
27 June
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:
Tuesday 27 June 2017, London UK - LSE Announcement
GSK starts phase III study with mepolizumab in patients with nasal
polyps
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 bilateral nasal polyps.
Nasal
polyps is a chronic inflammatory disease of the nasal passage
linings or sinuses leading to soft tissue growth in the upper nasal
cavity. The resultant swellings can grow in both nostrils
(bilateral) greatly impacting a patient's quality of life due to
nasal obstruction, post nasal drip, loss of smell, facial pain,
facial pressure and nasal discharge. The current standard of care
is treatment with intranasal corticosteroids and, for severe cases,
oral corticosteroids. Surgery to remove the polyp tissue may also
be indicated for severe cases however polyps have a strong tendency
to reoccur often requiring repeat surgery.
The
study will assess the efficacy and safety of subcutaneous
mepolizumab 100mg compared to placebo, administered using a
pre-filled syringe every 4 weeks for 52 weeks, on top of standard
of care in 400 adult patients with recurrent severe bilateral nasal
polyps. The co-primary endpoint of the study is the change from
baseline in the total nasal polyps score (sum of left and right
nostril score) assessed by endoscopy at week 52 and nasal
obstruction, as measured using the visual analogue scale (VAS)
symptom score during the four weeks prior to week 52. The key
secondary endpoint is the time to first actual surgery for nasal
polyps by week 52. The study is anticipated to complete in
2019.
Steve
Yancey, Vice President and Medicine Development Leader for
mepolizumab, said, "We are pleased to start this study which builds
on our existing programmes to investigate mepolizumab in a range of
eosinophilic diseases. In general, nasal polyps may be considered a
benign disease but in severe cases it can have a significant impact
on a patient's day-to-day living. Our aim is to see whether
mepolizumab can improve symptoms, reduce nasal polyp size and
reduce the need for surgery in these patients despite optimal
medical management."
About the phase III study
The pivotal phase III study
named SYNAPSE,
StudY in NAsal Polyps patients to assess the
Safety and Efficacy of mepolizumab, is a 52-week, randomised,
double-blind, parallel group study. Throughout the study period,
patients will receive standard of care for nasal polyps consisting
of daily mometasone furoate nasal spray, and if required, saline
nasal douching, occasional short courses of high dose oral
corticosteroids and/or antibiotics. Patients with severe bilateral
nasal polyps were defined as those with an average nasal
obstruction VAS symptom score > 5 and an endoscopic score of at
least 5 out of a maximum score of 8, with a minimum score of 2 in
each nasal cavity. Patients must also have a history of at least
one prior surgery for nasal polyps, have recurrent nasal polyps
despite treatment with standard of care and be in need of nasal
polyp surgery.
Mepolizumab
is not approved for use anywhere in the world for nasal polyps. The
results of this study will inform any regulatory filing plans in
this indication.
About mepolizumab
Mepolizumab
is a targeted anti-IL-5 monoclonal antibody. Mepolizumab binds to
the signalling protein IL-5, preventing it from binding to its
receptor on the surface of white blood cells called eosinophils.
Inhibiting IL-5 binding in this way reduces blood, tissue and
sputum eosinophil levels.
Eosinophils
are believed to play a role in protecting the body against
infection. In some people, increased eosinophil levels can lead to
inflammation and play a role in the development of some
inflammatory diseases.
Mepolizumab
has been developed for the treatment of diseases that are driven by
inflammation caused by eosinophils.
Mepolizumab
is approved for use in the US, under the brand name Nucala, as the
first-in-class add-on maintenance treatment for patients with
severe asthma aged 12 years and older, and 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
.
Nucala
has also been approved for severe eosinophilic asthma in the EU,
Japan and a number of other countries worldwide although the
details of the indications may vary, with further regulatory
applications submitted and under review in other
countries.
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 polyangiitis (EPGA, also referred to as
Churg-Strauss syndrome, in
phase
III
), severe hypereosinophilic
syndrome (in
phase
III
), and severe atopic
dermatitis (phase II).
Nucala
®
is a registered trade mark of the GSK
group of companies.
Important Safety Information for Nucala
The following information is based on the US Prescribing
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. Reports of anaphylaxis have been received
postmarketing.
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
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
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 2016.
|
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: June
27, 2017
|
|
|
|
|
By: VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|
GSK (NYSE:GSK)
Historical Stock Chart
From Aug 2024 to Sep 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Sep 2023 to Sep 2024