TIDMGSK
RNS Number : 2878J
GlaxoSmithKline PLC
27 June 2017
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(R) 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 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
Namrata Taak +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Alspach +1 202 715 (Washington,
1048 DC)
Sarah Spencer +1 215 751 (Philadelphia)
3335
Karen Hagens +1 919 483 (North Carolina)
2863
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5557
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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