a5943y
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 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
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
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Fasenra met both
co-primary endpoints of reduced nasal polyp size and blockage in
the OSTRO Phase III trial for patients with chronic rhinosinusitis
with nasal polyps
10 September 2020 07:00 BST
Fasenra met
both co-primary endpoints of reduced nasal polyp size and blockage
in the OSTRO Phase III trial for patients with chronic
rhinosinusitis with nasal polyps
High-level results from the OSTRO Phase III trial showed
AstraZeneca's Fasenra (benralizumab) compared with placebo
demonstrated a statistically significant improvement in the size of
nasal polyps and in nasal blockage in patients with chronic
rhinosinusitis with nasal polyps (CRSwNP).
Fasenra demonstrated a statistically significant
improvement in the endoscopic total nasal polyp score (NPS) and the
nasal blockage score (NBS) compared to placebo, in patients with
severe bilateral nasal polyposis who were still symptomatic despite
continued treatment with standard of care (SoC). SoC consists of
intranasal corticosteroids (INCS) and prior surgery and/or use of
systemic corticosteroids. Evaluation of NPS was based on a
physician assessment of polyp size during endoscopy. NBS
evaluation was based on a patient-reported symptoms
diary.
CRSwNP is an inflammatory disease associated with elevated
levels of eosinophils in the upper respiratory tract and
characterised by benign growths called nasal
polyps.1,2 Polyps
can cause nasal blockage and discharge, reduction or loss in
the sense of smell, sleep disturbances and other adverse effects on
quality of life.3-5
Professor Claus Bachert, Head of the Department of
Oto-Rhino-Laryngology and Chair of the Upper Airway Research
Laboratory, University Hospital Ghent, Belgium, the principal
investigator of the trial, said: "Chronic rhinosinusitis with nasal
polyps is difficult to treat and the underlying drivers and natural
history of the disease are not fully established. The OSTRO results
show that Fasenra's eosinophil-depleting mechanism of action may
benefit patients with this often debilitating
condition."
Mene Pangalos, Executive Vice President,
BioPharmaceuticals R&D, said: "Patients with chronic
rhinosinusitis with nasal polyps suffer significantly with nasal
congestion and a reduced quality of life. Current treatments, such
as intranasal or oral corticosteroids and surgery to remove polyps,
do not fully address patient needs. The OSTRO data
indicate Fasenra can benefit patients with nasal polyps. We
look forward to completing the full analysis and sharing these
results at an upcoming medical meeting."
The safety profile and tolerability
of Fasenra in this trial were consistent with the known
profile of the medicine.
Fasenra is currently approved as an add-on
maintenance treatment for severe eosinophilic asthma in the US, EU,
Japan and other countries and is approved for self-administration
in the US, EU and other countries.
Chronic rhinosinusitis with nasal polyps
Chronic rhinosinusitis with nasal polyps (CRSwNP) is
characterised by persistent inflammation of the mucous membrane
lining the nasal passages and sinuses accompanied by benign
growths, called nasal polyps.6,7 Nasal
polyps can block nasal passages and lead to breathing problems,
reduction in the sense of smell, nasal discharge, sleep disturbance
and other adverse effects on quality of life.3-5 The
disease is associated with elevated levels of eosinophils, a type
of white blood cell, accumulating in the upper respiratory
tract.2
Current treatments for nasal polyps include intranasal or oral
corticosteroids (OCS) and surgery to remove polyps, but these often
do not address the underlying cause of the disease and the need for
repeated interventions can be high. Since 2019, other biologic
medicines have been approved or recommended to treat nasal
polyps.4,10
OSTRO is part of AstraZeneca's clinical trial programme
for Fasenra in CRSwNP which also includes the ongoing
Phase III ORCHID trial, among others.11
OSTRO
OSTRO is a randomised, double-blinded, multi-centre,
parallel-group, 56-week Phase III trial to evaluate the efficacy
and safety of Fasenra compared to placebo in patients with nasal
polyposis.12 Fasenra was
evaluated in patients, regardless of blood eosinophil count with or
without asthma, who were symptomatic despite SoC therapy, including
current use of INCS and prior surgery and/or use of systemic
corticosteroids. Patients were randomised to receive
either Fasenra 30mg or placebo subcutaneously every four
weeks for the first three doses and every eight weeks
thereafter.12
The primary outcome measures of the trial were: the effect
of Fasenra on nasal polyp burden, assessed by change
from baseline in endoscopic total NPS, at week 40 compared to
placebo; the effect of Fasenra on patient-reported nasal blockage, assessed
by change from baseline in mean NBS, at week 40 compared to
placebo. OSTRO involved 413 patients in Europe and North
America.12
Fasenra
Fasenra (benralizumab) is
a monoclonal antibody that binds directly to IL-5 receptor alpha on
eosinophils and attracts natural killer cells to induce rapid and
near-complete depletion of eosinophils via apoptosis (programmed
cell death).13,14
Fasenra is in development
for other eosinophilic diseases and chronic obstructive pulmonary
disease.15-19 The
US Food and Drug Administration granted Orphan Drug Designation
for Fasenra for the treatment of eosinophilic
granulomatosis with polyangiitis in 2018, and hypereosinophilic
syndrome and eosinophilic oesophagitis in 2019.
Fasenra was developed by
AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned
subsidiary of Kyowa Kirin Co., Ltd., Japan.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology is one of AstraZeneca's three therapy
areas and is a key growth driver for the Company.
Building on a 50-year heritage, AstraZeneca is an established
leader in respiratory care across inhaled and biologic medicines.
AstraZeneca aims to transform the treatment of asthma and chronic
obstructive pulmonary disease (COPD) by eliminating preventable
asthma attacks across all severities and removing COPD as a leading
cause of death through earlier, biology-led treatment. The
Company's early respiratory research is focused on emerging science
involving immune mechanisms, lung damage and abnormal cell repair
processes in disease and neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immune-driven diseases. The Company's
growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential in rheumatology
(including systemic lupus erythematosus), dermatology,
gastroenterology and systemic eosinophilic-driven diseases.
AstraZeneca's ambition in immunology is to achieve disease control
and ultimately clinical remission in targeted immune-driven
diseases.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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, Renal and Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. American Academy
of Allergy Asthma & Immunology. Nasal Polyps. Available
at: https://www.aaaai.org/conditions-and-treatments/library/allergy-library/nasal-polyps.[Last
accessed: September 2020].
2. Fujieda S Imoto Y, Kato
Y, et
al. Eosinophilic chronic
rhinosinusitis. Allergology
Int. 2019; 68 (4):
403-412.
3. Hopkins C. Chronic Rhinosinusitis
with Nasal Polyps. N Engl J
Med. 2019; 381 (1):
55-63.
4. Stevens WW, Schleimer RP, Kern RC.
Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol
Pract. 2016; 4 (4):
565-572.
5. Abdalla S, Alreefy H, Hopkins C.
Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients
undergoing surgery for chronic rhinosinusitis in the England and
Wales National prospective audit. Clin
Otolaryngol. 2012; 37 (4):
276-282.
6. Bachert C, Akdis CA. Phenotypes and
Emerging Endotypes of Chronic
Rhinosinusitis. J Allergy Clin Immunol
Pract. 2016; 4 (4):
621-628.
7. Newton JR, Ah-See KW. A review of
nasal polyposis. Ther Clin Risk
Manag. 2008; 4 (2):
507-512.
8. Ramirez GA, Yacoub MR, Ripa
M, et
al. Eosinophils from physiology
to disease: a comprehensive review. Biomed Res
Int. 2018;
9095275.
9. Gelardi M, Piccininni K, Quaranta
A, et
al. Olfactory dysfunction
in patients with chronic rhinosinusitis with nasal polyps is
associated with clinical-cytological grading
severity. Acta Otorhinolaryngol
Ital. 2019;39:329-335.
10.
CHMP Opinion. Xolair. Available at:
https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xolair-ii-101_en.pdf.
[Last accessed: September 2020].
11. Clinicaltrials.gov.
Efficacy and Safety Study of Benralizumab in Patient With
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID).
Available at: https://clinicaltrials.gov/ct2/show/NCT04157335.
[Last accessed: September 2020].
12.
Clinicaltrials.gov. Efficacy and Safety Study of Benralizumab for
Patients With Severe Nasal Polyposis (OSTRO). Available at:
https://clinicaltrials.gov/ct2/show/NCT03401229. [Last accessed:
September 2020].
13. Kolbeck R, Kozhich A,
Koike M, et al. MEDI-563, a humanized anti-IL-5 receptor
a mAb with enhanced antibody-dependent cell-mediated
cytotoxicity function. J Allergy Clin
Immunol. 2010; 125 (6):
1344-1353.e2.
14. Pham TH, Damera G, Newbold P,
Ranade K. Reductions in eosinophil biomarkers by benralizumab in
patients with asthma. Respir Med. 2016; 111: 21-29.
15. Clinicaltrials.gov.
Effect of Benralizumab in Atopic Dermatitis. Available
at: https://clinicaltrials.gov/ct2/show/NCT03563066 [Last
accessed: September 2020].
16.
AstraZeneca data on file (MESSINA trial).
17. Clinicaltrials.gov. A
Study to Evaluate if Benralizumab Compared to Mepolizumab May be
Beneficial in the Treatment of Eosinophilic Granulomatosis With
Polyangiitis (EGPA) (MANDARA). Available
at: https://clinicaltrials.gov/ct2/show/NCT04157348.
[Last accessed: September 2020].
18. Clinicaltrials.gov. A
Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab
in Patients With Hypereosinophilic Syndrome (HES) (NATRON).
Available at: https://clinicaltrials.gov/ct2/show/NCT04191304 [Last
accessed: September 2020].
19. Clinicaltrials.gov.
Efficacy and Safety of Benralizumab in Moderate to Very Severe
Chronic Obstructive Pulmonary Disease (COPD) With a History of
Frequent Exacerbations (RESOLUTE). Available
at: https://clinicaltrials.gov/ct2/show/NCT04053634 [Last
accessed: September 2020].
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:
10 September
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|