MedImmune announced
that it has initiated enrollment in a Phase 2A trial with an
investigational human monoclonal antibody (MAb) targeting interferon-alpha
in patients with systemic lupus erythematosus (SLE or lupus). The study is
designed to assess the safety and tolerability of the antibody, also known
as MEDI-545 in patients with moderately to severely active lupus, despite
standard of care. Current treatment options for moderately to severely
active lupus include potent immunosuppressive drugs that have unfavourable
long-term adverse effects. Data from patients with lupus and animal models
of lupus suggest Type I interferons play a key role in lupus, especially
interferon-alpha. By blocking the effects of interferon-alpha, MEDI-545 may
provide a strategy for improving the signs and symptoms associated with
lupus.
"Lupus can be a debilitating disease that damages organs, causes pain
and loss of function, and reduces the quality of life in patients suffering
from the disease, who are often young women," said Barbara White, vice
president, clinical development, inflammatory disease. "The Phase 1 trials
with this antibody have demonstrated that it can inhibit activity of
interferon-alpha in patients with lupus and that its safety profile
supports further clinical development in lupus."
The Phase 2A clinical trial is designed to evaluate the safety and
tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo
in adult patients with moderately to severely active lupus. The study will
also assess the effects of MEDI-545 on disease activity in lupus patients.
This randomized, double-blind, placebo-controlled, parallel-dose trial will
be conducted at about 20 sites throughout the United States.
MEDI-545 was generated by immunizing the Medarex transgenic
HuMab-Mouse(R) with natural human interferon-alpha.
About Lupus
Lupus is an autoimmune disease that can affect various parts of the
body, including the skin, joints, heart, lungs, blood, kidneys and brain.
Lupus affects approximately 322,000 to possibly over a million people in
the United States. Lupus may occur at any age in men or women, but the
disease predominantly affects women of childbearing years. The disease has
a higher incidence in African-Americans, Hispanics, Asian and American
Indians. Treatments for lupus include nonsteroidal anti-inflammatory drugs,
corticosteroids, antimalarials, and immunosuppressants.
About MedImmune
MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN)
and is the worldwide biologics business for the AstraZeneca Group. The
company has approximately 3,000 employees worldwide and is headquartered in
Gaithersburg, Maryland. MedImmune strives to provide better medicines to
patients, new medical options for physicians and rewarding careers to
employees. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on infection, oncology, respiratory
disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience.
For more information, visit MedImmune's website at
medimmune.
MedImmune
medimmune