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2014-05-12

AstraZeneca: AstraZeneca announces Medimmune's mavrilimumab and sifalimumab both met primary endpoints in phase IIb studies

Mavrilimumab produces rapid improvement in signs and symptoms of
rheumatoid arthritis, measures of disability and patient-reported
outcomes

Sifalimumab meets primary endpoint of reduction in global disease
activity score (SRI-4), and shows clinically important improvement in
skin and joint symptoms, patient reported outcomes in patients with
moderate/severe systemic lupus erythematosus

AstraZeneca today announced that two key molecules in MedImmune's
Respiratory, Inflammation and Autoimmune (RIA) portfolio -
mavrilimumab and sifalimumab - met their primary endpoints in
respective Phase II studies, demonstrating further pipeline progress
in core therapeutic areas.

Top-line results from the Phase IIb study of mavrilimumab, an
investigational monoclonal antibody that inhibits a key pathway in
the development of rheumatoid arthritis (RA), achieved its primary
endpoints. In the Phase llb study of a methotrexate inadequate
responder RA population (EARTH EXPLORER-1), 326 patients with
moderate and severe RA were treated for six months with either
mavrilimumab (low, medium or high dose) or placebo in addition to
standard methotrexate background therapy. The co-primary endpoints of
the American College of Rheumatology (ACR) response of ACR20 and
Disease Activity Score (DAS28) were met with all mavrilimumab doses
confirming the efficacy demonstrated in the previous Phase IIa study
(EARTH).

The high dose was the most effective with an ACR20 response at week 24
of 73.4 percent vs 24.7 percent for placebo (p<0.001) and a reduction
in mean DAS28 score at day 85 of -1.9 vs -0.68 for placebo (p<0.001).
Additionally, all secondary endpoints including ACR50, ACR70 response
and DAS28 remission score achieved statistical significance for the
high dose. Mavrilimumab also produced rapid improvement in the
multiple symptoms of rheumatoid arthritis and significant
improvements in patient reported outcomes including disability, pain
and fatigue. The safety findings observed were consistent with those
previously reported for the Phase IIa study. The most
commonly-reported adverse events (>3 percent) included headache,
nasopharyngitis (common cold), hypertension, bronchitis and worsening
of RA.

"Through innovative, novel research, MedImmune has built a diverse
emerging pipeline in Respiratory, Inflammation and Autoimmune
disease, covering a broad set of patients. We are focused on
advancing data and drug discovery to improve treatment options and
clinical outcomes for patients," said Dr. Bahija Jallal, Executive
Vice President, MedImmune. "Compelling Phase II data from two of our
molecules - mavrilimumab for rheumatoid arthritis and sifalimumab for
systemic lupus - further confirm our commitment to bringing new
medicines to patients as quickly as possible."

MedImmune also announced top-line results from the Phase II study of
sifalimumab (MEDI-545), a novel monoclonal antibody being
investigated as a treatment for patients with moderate/severe
systemic lupus erythematosus (SLE or lupus). The study met its
primary endpoint of percentage of subjects that responded by the SLE
Responder Index (SRI-4) at Day 365. Clinically important improvements
in organ-specific outcome measures (joint, skin) and patient reported
outcomes were also observed.

In the study, three doses of sifalimumab were evaluated against
placebo when added to stable standard of care therapy in patients
with moderately to severely active lupus despite standard of care
therapy. In addition to efficacy in the primary endpoint, there is a
broad-based body of clinical evidence supporting the efficacy of
sifalimumab. The study achieved two secondary endpoints at specific
doses - improvement in skin (rashes) as measured by CLASI (Cutaneous
Lupus Erythematosus Disease Area and Severity Index) and improvement
in fatigue. Sifalimumab demonstrated an overall acceptable safety
profile, with a numerical increase in the incidence of Herpes Zoster
reactivations.

"Patients with lupus have severely limited options for control of
their symptoms, as only one new treatment has been approved in more
than 50 years," said Dr. Bing Yao, Senior Vice President and Head of
MedImmune's Respiratory, Inflammation and Autoimmunity Innovative
Medicines Unit. "There is clearly a sense of urgency to deliver new
treatments for patients suffering from this debilitating, chronic
disease, and we are hopeful that we will be able to offer a new
option."

The company anticipates presenting additional study results for both
molecules at a future medical conference later this year. The Phase
II programme in lupus with anifrolumab (MEDI-546), which targets the
type 1 interferon receptor, is also ongoing.

- ENDS -

NOTES TO EDITORS

About Rheumatoid Arthritis (RA)

Rheumatoid arthritis is a painful, systemic, chronic inflammatory
autoimmune disease which causes damage to the joints and vital
organs. The disease affects approximately one in 100 people
worldwide. If not adequately treated, RA is a major cause of
disability leading to diminished work capacity and is associated with
reduced life expectancy. The American College of Rheumatology (ACR)
response represents a percentage improvement in symptoms. To achieve
an ACR20 score, a person with RA must have at least 20 percent fewer
tender joints and at least 20 percent fewer swollen joints. In
addition the patient must also have a 20 percent improvement in at
least three of the following five areas: 1) the patients overall
(global) assessment of their RA 2) the patient assessment of their
pain 3) the patients assessment of their physical functioning 4) the
physician's global assessment of their patients RA, and 5) the
results of a C-reactive protein and erythrocyte sedimentation rate
blood test as key indicators of inflammation.

The Disease Activity Score (DAS) represents an assessment of disease
symptoms. The DAS score consists of a numerical assessment of a set
of 28 joints for swelling and tenderness, plus the patients overall
(global) assessment of their RA and the results of a C-reactive
protein and erythrocyte sedimentation rate blood test as key
indicators of inflammation.

About Lupus

Lupus is an autoimmune disease in which the immune system produces
antibodies that, instead of targeting viruses or other foreign
invaders, attacks healthy tissue in the body, including skin, joints,
the brain, and blood vessels. Lupus can cause a range of symptoms,
including pain, rashes, fatigue, swelling in joints, and fevers, and
is associated with a higher risk of death from causes such as
infection and cardiovascular disease.

The SLE Responder Index-4 represents a clinically significant
improvement in lupus disease activity. To achieve SRI-4 response, a
person with lupus must have at least a 4 point improvement on the SLE
Disease Activity - 2K (SLEDAI-2K) score, a validated measure of
disease activity and have no worsening on the Physician Global
Assessment of disease activity and the BILAG (British Isles Lupus
Assessment Group) disease activity index.

About Mavrilimumab

Mavrilimumab (formerly CAM-3001) is a first in class human monoclonal
antibody that targets the alpha receptor for the cytokine
granulocyte-macrophage colony-stimulating factor (GM-CSF). Through
the targeted blockade of the receptor on the macrophage, a key cell
in the pathogenesis of rheumatoid arthritis, mavrilimumab could add a
significant new treatment option for RA patients.

About Sifalimumab

Sifalimumab (formerly MEDI-545) is an investigational human monoclonal
antibody that targets IFN-α, a type of inflammatory cytokine in the
body known to play a role in the development of SLE. Previous studies
have shown that high levels of type I IFN-α are correlated with more
severe disease activity in SLE patients, and early studies of
sifalimumab have demonstrated that this agent blocks signaling of all
interferon alpha subtypes.

About MedImmune

MedImmune is the global biologics research and development arm of
AstraZeneca. MedImmune is pioneering innovative research and
exploring novel pathways across key therapeutic areas, including
respiratory, inflammation and autoimmunity; cardiovascular and
metabolic disease; oncology; neuroscience; and infection and
vaccines. The MedImmune headquarters is located in Gaithersburg, Md.,
one of AstraZeneca's three global R&D centres. For more information,
please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. 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

CONTACTS

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