Patients With Lupu
A study to evaluate the safety and tolerability of multiple doses of the MAb in patients with systemic lupus erythematosus (SLE or lupus).
Disease
MedImmune has begun dosing patients in a multi-dose, Phase 1b clinical trial with its monoclonal antibody (MAb) targeting interferon-alpha, known as MEDI-545. The trial is the third clinical study underway with the antibody, which is also being evaluated in a single-dose Phase 1 trial in lupus patients and a Phase 1 study in patients with psoriasis.
"This multi-dose study marks an important milestone in MedImmune's efforts to develop innovative treatments for inflammatory diseases such as lupus," said Barbara White, vice president, clinical development, inflammatory disease. "Our therapeutic approach to addressing this area of high unmet medical need is supported by increasing evidence of type-1 interferon involvement in the pathology of immune system disorders, and we are pleased to extend clinical evaluation of our anti-interferon-alpha MAb to a second Phase 1 study in this patient population."
The Phase 1b trial will build on preliminary data from the ongoing Phase 1 study in lupus patients, as described in a presentation at the 8th International Lupus Consortium held May 24-26, 2007 in Shanghai. Early results from the single-dose trial show an acceptable safety profile and tolerability of MEDI-545.
In addition to advancing MEDI-545 as a potential treatment for lupus, with two Phase 1 trials underway, MedImmune has recently expanded the anti-interferon-alpha program to include other potential disease areas. The company initiated a Phase 1 trial in patients with psoriasis earlier in 2007 and plans to begin a trial in idiopathic inflammatory myopathies later this year.
MEDI-545 is a fully human MAb targeting interferon-alpha. Published data indicate that levels of interferon-alpha are elevated in many patients with active SLE and other autoimmune disorders, and may be associated with disease activity. Preclinical data from animal models suggest that MEDI-545 may suppress the abnormal immune activity associated with lupus by binding to the pattern of multiple interferon-alpha subtypes seen in the serum of lupus patients.
Approximately 350,000 individuals in the United States are affected
with lupus, a chronic inflammatory disease that causes the body to attack
its own tissues and organs, including the skin, joints, blood and kidneys.
Treatments for lupus include anti-inflammatory drugs, antimalarials, corticosteroids and drugs approved for other purposes, such as immunosuppressive agents given to cancer patients undergoing chemotherapy or medicines developed to treat arthritis patients. Lupus occurs about 10 times more frequently in adult females than adult males, and is two to three times more common among African Americans, Hispanics, Asians and Native Americans.