Bli medlem
Bli medlem

Du är här

2018-12-20

AstraZeneca: Phase III OLYMPUS and ROCKIES trials for roxadustat met their primary endpoints in chronic kidney disease pati...

OLYMPUS demonstrated a statistically-significant and
clinically-meaningful improvement in haemoglobin vs. placebo in
non-dialysis-dependent patients

ROCKIES demonstrated a statistically-significant improvement in
haemoglobin vs. epoetin alfa in dialysis-dependent patients

AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES
trials for roxadustat each met their primary efficacy endpoints for
the treatment of patients with anaemia in chronic kidney disease
(CKD) that are either non-dialysis-dependent or dialysis-dependent,
respectively. Roxadustat is a hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI) and a potential first-in-class new
medicine to treat anaemia in CKD being jointly developed and
commercialised by AstraZeneca and FibroGen, Inc.

OLYMPUS is a Phase III, randomised, double-blinded, placebo-controlled
trial designed to evaluate the efficacy and safety of roxadustat vs.
placebo for the treatment of patients with anaemia in CKD stages 3, 4
and 5 whose disease progression is moderate to severe and who are
non-dialysis dependent.1 The trial met its primary efficacy endpoint
by demonstrating a statistically-significant and
clinically-meaningful improvement in mean change from baseline in
haemoglobin (Hb) levels averaged over weeks 28 to 52 vs. placebo.1
The trial evaluated 2,781 patients in 26 countries.

ROCKIES is a Phase III, randomised, open-label, active-controlled
trial designed to assess the efficacy and safety of roxadustat vs.
epoetin alfa, for the treatment of patients with anaemia in CKD who
are dialysis dependent.2 The trial met its primary efficacy endpoint
by demonstrating a statistically-significant improvement in mean
change from baseline in Hb levels averaged over weeks 28 to 52 vs.
epoetin alfa.2 The trial evaluated 2,133 patients in 18 countries.

The global Phase III programme consists of more than 9,000 patients in
trials conducted by AstraZeneca, FibroGen and Astellas. In September
2018, Astellas announced high-level results from the Phase III ALPS
trial. FibroGen and Astellas anticipate reporting high-level results
from their remaining trials in due course. These trials will
contribute to the combined pooled safety analysis, including major
adverse cardiovascular event (MACE) outcomes, anticipated during H1
2019.

Sean Bohen, Executive Vice-President, Global Medicines Development and
Chief Medical Officer, said: "These results add to the growing body
of evidence for roxadustat, which is part of the largest clinical
programme worldwide in evaluating the novel class of HIF-PHI. This is
a significant milestone in the role roxadustat can play to help
address a high unmet need in anaemia associated with chronic kidney
disease, which today is under diagnosed and in many cases under
treated."

Data from the Phase III OLYMPUS and ROCKIES trials, together with the
efficacy and pooled safety data from the global Phase III programme,
will be part of the regulatory submission package in the US and other
major countries. Results from these trials will be presented at
forthcoming medical meetings.

About roxadustat

Roxadustat is a first-in-class, orally-administered small-molecule
medicine recently approved in China for the treatment of patients
with anaemia from CKD on dialysis. Roxadustat is a HIF-PHI that
promotes erythropoiesis by increasing endogenous production of
erythropoietin and improving iron regulation and overcoming the
negative impact of inflammation on haemoglobin synthesis and red
blood cell production by downregulating hepcidin. Administration of
roxadustat has been shown to induce coordinated erythropoiesis,
increasing red blood cell count while maintaining plasma
erythropoietin levels within or near normal physiologic range, in
multiple subpopulations of CKD patients, including in the presence of
inflammation and without a need for supplemental intravenous (IV)
iron.

AstraZeneca and FibroGen, Inc. are collaborating on the development
and commercialisation of roxadustat for the treatment of anaemia in
patients with CKD in the US, China, and other global markets.
FibroGen and Astellas are collaborating on the development and
commercialisation of roxadustat for the treatment of anaemia in
patients with CKD in Japan, Europe, the Commonwealth of Independent
States, the Middle East, and South Africa.

About anaemia in CKD

Anaemia can be a serious medical condition in which patients have
insufficient red blood cells and low levels of Hb, a protein in red
blood cells that carries oxygen to cells throughout the body.3,4
Anaemia in CKD is associated with increased risk of hospitalisation,
cardiovascular complications and death,5 also frequently causing
significant fatigue, cognitive dysfunction and decreased quality of
life.6 Severe anaemia is common in patients with CKD, cancer,
myelodysplastic syndrome, inflammatory diseases, and other serious
illnesses.

Anaemia is particularly prevalent in patients with CKD, which affects
more than 200 million people worldwide and is generally a progressive
disease characterised by gradual loss of kidney function that may
eventually lead to kidney failure.

In the US, according to the United States Renal Data System (USRDS), a
majority of dialysis-eligible CKD patients are currently on dialysis.
Of the approximately 507,000 patients receiving dialysis in the US as
of 2016, approximately 80% were being treated with ESAs for anaemia.7
Patients seldom receive ESA treatment until they initiate dialysis
therapy.

About FibroGen

FibroGen, Inc., headquartered in San Francisco, California, with
subsidiary offices in Beijing and Shanghai, People's Republic of
China, is a leading biopharmaceutical company discovering and
developing a pipeline of first-in-class therapeutics. The company
applies its pioneering expertise in hypoxia-inducible factor (HIF),
connective tissue growth factor (CTGF) biology, and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Roxadustat, the company's most
advanced product candidate, is an oral small molecule inhibitor of
HIF prolyl hydroxylase activity, completing worldwide Phase 3
clinical development for the treatment of anemia in chronic kidney
disease (CKD), with a New Drug Application (NDA) now approved by the
National Medical Products Administration (NMPA) in China. FibroGen's
partner Astellas submitted an NDA for the treatment of anemia in CKD
patients on dialysis in Japan in September 2018, currently under
review by the Pharmaceuticals and Medical Devices Agency (PMDA).
Roxadustat is in Phase 3 clinical development in the U.S. and Europe
and in Phase 2/3 development in China for anemia associated with
myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF human
monoclonal antibody, is advancing towards Phase 3 clinical
development for the treatment of idiopathic pulmonary fibrosis (IPF)
and pancreatic cancer, and is currently in a Phase 2 trial for
Duchenne muscular dystrophy (DMD). FibroGen is also developing a
biosynthetic cornea in China. For more information, please visit
www.fibrogen.com.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and a key growth driver for the
Company. By following the science to understand more clearly the
underlying links between the heart, kidneys and pancreas, AstraZeneca
is investing in a portfolio of medicines to protect organs and
improve outcomes by slowing disease progression, reducing risks and
tackling co-morbidities. Our ambition is to modify or halt the
natural course of CVRM diseases and potentially regenerate organs and
restore function, by continuing to deliver transformative science
that improves treatment practices and cardiovascular health for
millions of patients worldwide.

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, Renal & Metabolism
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
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Media Relations
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jennifer Hursit UK/Global +44 203 749 5762
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Cardiovascular; Metabolism +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
Josie Afolabi Other +44 203 749 5631
Craig Marks Finance; Fixed Income +44 7881 615 764
Jennifer Kretzmann Retail Investors +44 203 749 5824
US toll-free +1 866 381 7277

References

1. Clinicaltrials.gov. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis. [Online]. Available at:

https://clinicaltrials.gov/ct2/show/record/NCT02174627. Last accessed:
September 2018.

2. Clinicaltrials.gov. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis. [Online].

Available at: https://clinicaltrials.gov/ct2/show/record/NCT02174731.
Last accessed: September 2018.

3. National Kidney Foundation. "Managing Anaemia When You Have Kidney Disease or Kidney Failure." 2014.

4. National Institute of Diabetes and Digestive and Kidney Diseases. "Anaemia in Chronic Kidney Disease." 2014.

5. Babitt JL, Lin HY. Mechanisms of Anemia in CKD. J Am Soc Nephrol (2012); 23:1631-1634

6. KDOQI Clinial Practice Guidelines and Clinical Practice Recommendations for Anaemia in Chronic Kidney Disease. Am J Kidney Dis. 2006 May;47(5):S1-S132

7. United States Renal Data System. "Annual Data Report." 2017.

-----------------------------------------------------------
http://news.cision.com/se/astrazeneca/r/phase-iii-olympus-and-rockies-tr...

Författare Cision

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.