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 August
2019
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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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Anifrolumab
Phase III trial meets primary endpoint in systemic lupus
erythematosus
This announcement contains inside information
29
August 2019 07:00 BST
Anifrolumab Phase III trial meets primary endpoint in
systemic lupus erythematosus
Positive top-line results from TULIP 2 trial demonstrate
a
statistically-significant and clinically-meaningful reduction
in
disease activity based on composite lupus assessment
AstraZeneca today announced that the Phase III TULIP 2 trial for
anifrolumab, a potential new medicine for the treatment of systemic
lupus erythematosus (SLE), met its primary endpoint, achieving a
statistically-significant and clinically-meaningful reduction in
disease activity versus placebo, with both arms receiving standard
of care.
The reduction was measured using the British Isles
Lupus Assessment Group based Composite Lupus Assessment (BICLA) at
week 52. The BICLA requires improvement in all organs with disease
activity at baseline with no new flares.1 The
safety profile of anifrolumab was consistent with previous
trials.
TULIP
2 was the second Phase III trial designed to assess the safety and
efficacy of anifrolumab as a treatment for adults with
moderate-to-severe SLE. The positive BICLA response in TULIP 2 was
consistent with a pre-specified analysis of the previous Phase III
TULIP 1 trial, which did not meet its primary endpoint of SLE
Responder Index 4 (SRI4).
Mene
Pangalos, Executive Vice President, BioPharmaceuticals R&D,
said: "Systemic lupus erythematosus is a debilitating autoimmune
disease, but only one new treatment has been approved in the last
60 years. These are important results and we will now review the
full data set and explore pathways to bring this potential new
treatment to patients."
Professor
Eric F. Morand, Monash University, Australia, and Principal
Investigator on the TULIP 2 trial said: "As clinicians we need new
medicines for this complex and difficult-to-treat disease. These
exciting results from the TULIP 2 trial demonstrate that, by
targeting the type I interferon receptor, anifrolumab reduced
disease activity in patients with systemic lupus
erythematosus."
Data from TULIP 1 and TULIP 2 will be submitted for presentation at
a forthcoming medical meeting.
About anifrolumab
Anifrolumab is a fully human monoclonal antibody that binds to
subunit 1 of the type I interferon receptor, blocking the activity
of all type I interferons including IFN-alpha, IFN-beta and
IFN-omega.2 Type
I interferons are cytokines involved in the inflammatory
pathways.3 Between
60% and 80% of adults with SLE have an increased type I interferon
gene signature, which has been shown to correlate with disease
activity.3,4
About the Phase III TULIP programme
The pivotal TULIP (Treatment of Uncontrolled Lupus via the
Interferon Pathway) programme includes two Phase III clinical
trials, TULIP 1 and TULIP 2, which evaluated the efficacy and
safety of anifrolumab versus placebo in patients with
moderately-to-severely active autoantibody-positive SLE who were
receiving standard of care treatment. Results from TULIP
1 were announced in August
2018.
TULIP 2 randomised 373 eligible patients (1:1) to receive a
fixed-dose intravenous infusion of 300mg anifrolumab or placebo
every four weeks. TULIP 2 assessed the effect of anifrolumab in
reducing disease activity, as measured by the BICLA. The BICLA
was chosen as the primary endpoint for TULIP 2 following a full
evaluation of TULIP 1 and is an established measurement for
disease activity in adults with SLE.5,6
TULIP 1 randomised 460 eligible patients (1:2:2) to receive a
fixed-dose intravenous infusion of 150mg anifrolumab, 300mg
anifrolumab or placebo every four weeks. TULIP 1 assessed the
effect of anifrolumab in reducing disease activity, as measured by
the SRI4.
In addition, the TULIP programme includes a Phase III long-term
extension trial in SLE and a Phase II trial in lupus
nephritis.
About systemic lupus erythematosus
SLE is an autoimmune disease in which the immune system attacks
healthy tissue in the body.7 It
is a chronic and complex disease with a variety of clinical
manifestations that can impact many organs and cause a range of
symptoms including pain, rashes, fatigue, swelling in joints and
fevers.8 It
is associated with a greater risk of death from causes such as
infection and cardiovascular disease.9 There
has been only one new medicine approved for SLE in the last 60
years.10
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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visitastrazeneca.com and
follow us on Twitter @AstraZeneca.
Media Relations
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. Mikdashi J, Nived O. Measuring disease activity in adults with
systemic lupus erythematosus: the challenges of administrative
burden and responsiveness to patient concerns in clinical
research. Arthritis Research &
Therapy.
2015;17(1):183.
2. Furie, Khamashta M, Merrill J T, et al. Anifrolumab, an
Anti-Interferon‐a
Receptor Monoclonal Antibody, in Moderate‐to‐Severe
Systemic Lupus Erythematosus. Arthritis &
Rheumatology.
2017;69(2);376-386.
3. Lauwerys BR, Ducreux J, Houssiau FA. Type I interferon blockade
in systemic lupus erythematosus: where do we
stand?. Rheumatology.
2013;53(8);1369-1376.
4. Crow, M. K, Type I Interferon in the Pathogenesis of
Lupus, The Journal of
Immunology.
2014;192(12);5459-5468.
5. Wallace D. et al. Evaluation of treatment success in systemic
lupus erythematosus clinical trials: development of the British
Isles Lupus Assessment Group-based composite lupus assessment
endpoint [poster]. Presented at: ACR/ARHP 2011 Annual Scientific
Sessions; November 5-9, 2011; Chicago, IL. Poster
2265.https://acr.confex.com/acr/2011/webprogram/Paper23976.html.
Accessed July 8, 2019.
6. Thanou A, Chackravarty E, James J et al. Which outcome measures
in SLE clinical trials best reflect medical
judgment? Lupus Science &
Medicine. 2014;1:e000005.
7. The Lupus Foundation of America. Available at
https://resources.lupus.org/entry/what-is-lupus?utm_source=lupusorg&utm_medium=answersFAQ.
[Accessed June 2019]
8. ACR. Guidelines for referral and management of systemic lupus
erythematosus in adults. American College of Rheumatology Ad Hoc
Committee on Systemic Lupus Erythematosus
Guidelines, Arthritis &
Rheumatism. 1999; 42;
1785-1796.
9. Nossent J, Cikes N, Kiss E, et al. Current causes of death
in systemic lupus erythematosus in Europe, 2000-2004: relation to
disease activity and damage accrual. Lupus. 2007;
16:309-317.
10. Mahieu, M. A., Strand, V, Simon, Lee, S.S et al. A critical
review of clinical trials in systemic lupus
erythematosus.Lupus. 2016;25(10);1122-1140.
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:
29 August
2019
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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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