Blueprint
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 the
month of September
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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82-_____________
7
September 2017 07:00 BST
TEZEPELUMAB SIGNIFICANTLY REDUCED ASTHMA EXACERBATIONS FOR A BROAD
POPULATION OF PATIENTS WITH SEVERE UNCONTROLLED ASTHMA
First-in-class treatment that
blocks thymic stromal lymphopoietin (TSLP) -
an upstream driver of inflammation in asthma
Results published today in New England Journal of
Medicine
Late-breaking abstract at European Respiratory Society
International Congress highlights results from the PATHWAY Phase
IIb trial of tezepelumab in patients with severe, uncontrolled
asthma
7
September 2017
AstraZeneca
and Amgen Inc. (Amgen) today announced results from the PATHWAY
Phase IIb trial of tezepelumab that showed a significant reduction
in the annual asthma exacerbation rate compared with placebo in
patients with severe, uncontrolled asthma. Tezepelumab is a
first-in-class anti-TSLP monoclonal antibody being developed by
MedImmune, AstraZeneca's global biologics research and development
arm, in collaboration with Amgen.
The
trial results were published today in the New England Journal of
Medicine, and will be followed by an oral presentation on 12
September at the ERS International Congress 2017 in
Milan.
The
PATHWAY trial achieved its primary efficacy endpoint, showing
annual asthma exacerbation rate reductions of 61%, 71% and 66% in
the tezepelumab arms receiving either 70mg or 210mg every four
weeks or 280mg every two weeks, respectively (p<0.001 for all
comparisons to placebo). In the trial, tezepelumab was given as an
add-on therapy to patients with a history of asthma exacerbations
and uncontrolled asthma despite receiving inhaled
corticosteroids/long-acting beta-agonists with or without oral
corticosteroids and additional asthma controllers.
Significant
and clinically-meaningful reductions in the exacerbation rate were
observed independent of baseline blood eosinophil count or other
type 2 (T2) inflammatory biomarkers. Tezepelumab also demonstrated
improvements in lung function at all doses and in asthma control at
the two higher doses (p<0.05 for all comparisons to placebo).
The incidence of adverse events was similar between the tezepelumab
and placebo groups. The most common adverse events (≥5%) in
tezepelumab-treated patients were asthma, nasopharyngitis,
headaches and bronchitis.
Dr
Jonathan Corren, David Geffen School of Medicine, UCLA and
Principal Investigator of the PATHWAY trial, said: "These efficacy
results strongly confirm that TSLP is an important mediator of
inflammation in severe asthma. Due to its activity early in the
inflammatory cascade, tezepelumab may be suitable for patients with
both T2 and non-T2 driven asthma, including those ineligible for
current biologic therapies which only target the T2
pathway."
Bahija
Jallal, Executive Vice President, Head of MedImmune, said: "In
asthma patients, TSLP functions as an upstream epithelial
'master-switch' right at the start of the inflammation cascade. By
binding to TSLP, tezepelumab impacts multiple downstream
inflammatory pathways associated with asthma, as shown by striking
reductions in the level of multiple biomarkers in the PATHWAY
trial, including blood eosinophils, IgE and FeNO. This broad
biomarker response is unprecedented among respiratory biologics and
reflects our commitment to leading respiratory science for unmet
medical needs."
TSLP is
an epithelial cytokine produced in response to pro-inflammatory
stimuli such as allergens, viruses and other pathogens in the lung.
It drives the release of downstream T2 cytokines including IL-4,
IL-5 and IL-13, leading to inflammation and asthma symptoms. TSLP
also activates many types of cells involved in non T2 driven
inflammation. Therefore, the early, upstream activity of TSLP in
the inflammation cascade has been identified as a potential target
across a broad asthma population.
- ENDS -
NOTES TO EDITORS
About Severe Asthma
Asthma
affects 315 million individuals worldwide, and up to 10% of asthma
patients have severe asthma, which may be uncontrolled despite high
doses of standard-of-care asthma controller medicines and can
require the use of chronic oral corticosteroids (OCS).
Severe,
uncontrolled asthma is debilitating and potentially fatal with
patients experiencing frequent exacerbations and significant
limitations on lung function and quality of life.
Severe,
uncontrolled asthma can lead to a dependence on OCS, with systemic
steroid exposure potentially leading to serious short- and
long-term adverse effects, including weight gain, diabetes,
osteoporosis, glaucoma, anxiety, depression, cardiovascular disease
and immunosuppression. There is also a significant physical and
socio-economic burden of severe, uncontrolled asthma with these
patients accounting for 50% of asthma-related costs.
T2
inflammation driven (T2 high) asthma is present in over two-thirds
of patients with severe asthma and is typically characterised by
elevated levels of T2 inflammatory biomarkers, including blood
eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).
Conversely, approximately one-third of patients with severe asthma
do not present with features of an activated T2 inflammatory
pathway, and no biologic treatment options currently exist for
these patients whose non-T2 driven disease is uncontrolled on
established standard of care therapies.
About Tezepelumab
Tezepelumab
is the first of a new kind of potential new medicines targeting
TSLP. Tezepelumab is a human anti-TSLP monoclonal antibody that
specifically binds human TSLP and prevents interaction with its
receptor complex. Blocking TSLP with tezepelumab may prevent the
release of pro-inflammatory cytokines by immune cells targeted by
TSLP, and thus prevent asthma exacerbations and improve asthma
control. Due to its activity early in the inflammation cascade,
tezepelumab may be suitable for a broad population of patients with
severe, uncontrolled asthma, including those whose asthma is not T2
driven. A previous proof-of-concept inhaled allergen challenge
study in patients with mild, atopic asthma, demonstrated that
tezepelumab inhibits early and late asthmatic responses and
suppresses biomarkers of type 2 inflammation. The results were
published in the New England Journal of Medicine in 2014.
Tezepelumab is being developed in collaboration with
Amgen.
About the PATHWAY Trial
The
PATHWAY trial was a Phase IIb 52-week, randomised, double-blind,
parallel group, placebo-controlled trial designed to evaluate the
efficacy and safety of three dose regimens of tezepelumab, 70mg and
210mg every four weeks and 280mg every two weeks, as an add-on
therapy in patients with a history of asthma exacerbations and
uncontrolled asthma receiving inhaled corticosteroids/long-acting
beta-agonist with or without oral corticosteroids and additional
asthma controllers.
About AstraZeneca in Respiratory Disease
Respiratory
disease is one of AstraZeneca's main therapy areas, and the Company
has a growing portfolio of medicines that reached more than 18
million patients in 2016. AstraZeneca's aim is to transform asthma
and COPD treatment through inhaled combinations at the core of
care, biologics for the unmet needs of specific patient
populations, and scientific advancements in disease
modification.
The
Company is building on a 40-year heritage in respiratory disease
and AstraZeneca's capability in inhalation technology spans both
pMDIs and dry powder inhalers, as well as the innovative
Co-SuspensionTM Delivery
Technology. The company's biologics include benralizumab
(anti-eosinophil, anti-IL-5rɑ), which has been accepted for
regulatory review in the US, EU and Japan, tralokinumab
(anti-IL-13), which is currently in Phase III, and tezepelumab
(anti-TSLP). AstraZeneca's research is focused on addressing
underlying disease drivers focusing on the lung epithelium, lung
immunity and lung regeneration.
About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Respiratory & Autoimmunity, Cardiovascular & Metabolic
Diseases, Oncology, and Infection and Vaccines. The MedImmune
headquarters is located in Gaithersburg, Md., one of AstraZeneca's
three global R&D centres, with additional sites in Cambridge,
UK and Mountain View, CA. For more information, please visit
www.medimmune.com
About AstraZeneca
AstraZeneca
is a global, science-led biopharmaceutical company that focuses on
the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three therapy
areas - Oncology, Cardiovascular & Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide.
For
more information, please visit www.astrazeneca.com
and follow us on Twitter @AstraZeneca.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
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 authorized.
Date:
7th
September 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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