TIDMAZN
RNS Number : 5254K
AstraZeneca PLC
29 August 2019
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 visit astrazeneca.com and follow us on Twitter
@AstraZeneca.
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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--<ALPHA> 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.
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