Blueprint
FORM
6-K/A
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 January 2018
Commission File
Number: 001-11960
AstraZeneca
PLC
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AstraZeneca
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INDEX
TO EXHIBITS
AZ
Reports Phase III Results for PT010 in COPD
26 January 2018 18:20 GMT
The
following amendments have been made to the 'AZ Reports Phase III
Results for PT010 in COPD' announcement released on
26/01/2018.
These
amendments are to correct text, delineating the PT010 superiority
primary endpoints from the comparator PT009 non-inferiority primary
endpoints:
●
Subhead amended from "eight out of
nine" to "six out of seven."
●
First sentence amended from "in eight
out of nine" to "compared with dual combination therapies in six
out of seven."
●
Body copy amended to include: "In
total, eight of the nine primary endpoints in the KRONOS trial were
met, including two non-inferiority endpoints to qualify PT009, one
of the comparators."
ASTRAZENECA REPORTS TOP-LINE PHASE III KRONOS TRIAL RESULTS FOR
PT010 TRIPLE COMBINATION THERAPY IN CHRONIC OBSTRUCTIVE PULMONARY
DISEASE
PT010 demonstrates significant improvement in six out of
seven lung function primary endpoints compared with dual
combination therapies
AstraZeneca
today announced top-line results from the Phase III KRONOS trial
that showed PT010 (budesonide/glycopyrronium/formoterol fumarate
320/14.4/9.6µg, using Aerosphere Delivery Technology, in a
pressurised metered-dose inhaler or pMDI) demonstrated a
statistically significant improvement compared with dual
combination therapies in six out of seven lung
function primary endpoints based on forced expiratory volume in one
second (FEV1) assessments in patients with moderate t six out of
seveno very severe chronic obstructive pulmonary disease
(COPD). In total, eight of the nine primary endpoints in the
KRONOS trial were met, including two non-inferiority endpoints to
qualify PT009, one of the comparators.
KRONOS
is a randomised, double-blind, parallel-group, 24-week,
chronic-dosing, multi-centre trial to assess the efficacy and
safety of PT010. The trial compared PT010 to Bevespi Aerosphere
(glycopyrronium/formoterol fumarate 14.4/9.6µg pMDI),
Symbicort Turbuhaler
(budesonide/formoterol fumarate 400/12µg) and PT009
(budesonide/formoterol fumarate 320/9.6µg using Aerosphere Delivery Technology in a
pMDI, being characterised to qualify as a relevant comparator in
clinical trials for PT010).1 Patients were given
two inhalations twice a day of PT010, PT009, Bevespi Aerosphere or Symbicort Turbuhaler.
There
were no unexpected safety or tolerability signals for PT010
identified in the trial.
Summary
of trial results:
|
Primary endpoint results assessed by FEV1
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PT010
vs Symbicort
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Over 24
weeks (post-dose*)
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Met
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PT010
vs Bevespi
Aerosphere
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Over 24
weeks (trough)
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Met
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Over
12-24 weeks (trough)
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Met
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At 24
weeks (trough)
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Not
met; favourable trend
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PT010
vs PT009
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Over 24
weeks (post-dose*)
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Met
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Over
12-24 weeks (trough)
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Met
|
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At 24
weeks (post-dose*)
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Met
|
|
PT009
vs Symbicort
(non-inferiority comparison)
|
|
Over 24
weeks (trough)
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Met
|
|
Over
12-24 weeks (trough)
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Met
|
*
Post-dose assessments FEV1 area under the curve 0-4
hours
Dr.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "We are encouraged by the results
of the KRONOS trial that has demonstrated PT010's efficacy in
improving lung function and look forward to the ETHOS exacerbation
trial results in 2019 that will further characterise the role of
this potential treatment for patients with COPD."
Klaus
Rabe, Professor of Pulmonary Medicine at the University of Kiel,
Director of the Department of Pneumology at Clinic Grosshansdorf,
Germany, and National Co-ordinating Investigator of the KRONOS
trial, said: "With the KRONOS trial, we are seeing the potential of
PT010 as a triple combination therapy for COPD. I expect the triple
class of medicines to play an increasingly important role in
addressing the needs of the many COPD patients who are currently
undertreated or are receiving triple combination therapy as
separate medicines in multiple devices."
The
KRONOS trial results will be presented at a forthcoming medical
meeting. AstraZeneca anticipates making regulatory submissions in
Japan and China in the second half of 2018, followed by potential
submissions in the US and Europe in 2019.
About COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.2
It affects an estimated 329 million
people worldwide3
and is predicted to be the
third-leading cause of death by 2020.2
Improving lung function, reducing
exacerbations and managing daily symptoms such as breathlessness
are important to the management of COPD. Today, approximately one
quarter of patients in Europe and the US are taking triple
combination therapy (inhaled corticosteroid (ICS)/long-acting
muscarinic antagonist (LAMA)/long-acting beta2-agonist
(LABA)), but delivered as separate medicines in multiple
devices.4,5
About PT010 and the
Aerosphere
portfolio
PT010 is a single inhaler, fixed-dose triple combination therapy of
budesonide, an ICS with glycopyrronium, a LAMA, and formoterol
fumarate, a LABA. It is being developed using AstraZeneca's
Aerosphere
Delivery Technology.
Aerosphere
Delivery Technology is also the
platform for the approved medicine Bevespi
Aerosphere.
About the ATHENA clinical trial programme
ATHENA is AstraZeneca's Phase III clinical trial programme for
PT010, which includes more than 15,500 patients globally across 11
trials.1,6,7,8
The four key trials are ETHOS, KRONOS,
TELOS and SOPHOS. ETHOS and TELOS include low and high doses of ICS
and stratification of patients by eosinophil levels as part of
randomisation, for PT010 and PT009 respectively.6,7
About Symbicort
Symbicort is a combination
formulation containing budesonide, an ICS, and formoterol, a LABA,
in a single inhaler. Symbicort is approved in approximately 120 countries to
treat COPD either as Symbicort Turbuhaler or Symbicort pMDI.
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 2017. 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
pressurised metered-dose inhalers and dry powder inhalers, as well
as the Aerosphere Delivery Technology. The company also has a
growing portfolio of respiratory biologics, including
Fasenra
(anti-eosinophil, anti-IL-5rɑ),
which is now approved in the US, EU and Japan respectively, and is
under regulatory review in other jurisdictions, and tezepelumab
(anti-TSLP), which achieved its Phase IIb primary and secondary
endpoints and is continuing development in the Phase III PATHFINDER
clinical trial programme. AstraZeneca's research is focused on
addressing underlying disease drivers focusing on the lung
epithelium, lung immunity and lung
regeneration.
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
References
1.
Clinicaltrials.gov. A Randomized, Double-Blind, Parallel-Group,
24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy
and Safety of PT010, PT003, and PT009 Compared With Symbicort®
Turbuhaler® (Kronos) (KRONOS). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT02497001.
Last accessed: January 2018.
2. GOLD. Global
Strategy for the Diagnosis, Management and Prevention of COPD,
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018.
[Online]. Available at: http://goldcopd.org.
Last accessed: January 2018.
3.
Bereza BG et al. Patient preferences in severe COPD and asthma: a
comprehensive literature review. International Journal of COPD.
2015: 10: 739-744.
4.
Wurst KE et al. Treatment evolution after COPD diagnosis in the UK
primary care setting. PLoS One. 2014: 9:e105296.
5. Simeone JC et al. Initiation of
triple therapy maintenance treatment among patients with COPD in
the US. Int
J Chron Obstruct Pulmon Dis.
2016;12:73-83.
6.
Clinicaltrials.gov. Study to Assess the Efficacy and Safety of
PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very
Severe COPD (ETHOS). [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT02465567
Last accessed:
January 2018.
7.
Clinicaltrials.gov. Study to Assess Efficacy and Safety of PT009
Compared to PT005, PT008, and Symbicort® Turbuhaler® on
Lung Function Over 24-Weeks in Subjects With Moderate to Very
Severe COPD (TELOS). [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT02766608.
Last accessed: January 2018.
8. Clinicaltrials.gov. A Study to
Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD
Exacerbations Over a 52-Week Period in Subjects With Moderate to
Very Severe COPD (SOPHOS). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT02727660.
Last accessed: January 2018.
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:
26 January 2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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|
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Title:
Company Secretary
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