Medarex, Inc announced that its partner MedImmune, Inc has initiated a phase-2A multi-dose clinical trial of MEDI-545 for the potential treatment of systemic lupus erythematosus (SLE or lupus). MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System. Under the terms of the agreement, Medarex will receive a milestone payment of an undisclosed amount.
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 moderate to severe active lupus. The study will also assess the effects of MEDI-545 on disease activity in lupus patients. This randomized, double-blind, placebo-controlled trial is expected to enrol 80 patients and will be conducted at 20 sites in the United States.
MedImmune is also conducting a phase-1 clinical trial for MEDI-545 in idiopathic inflammatory myositis, an immunological disease that involves chronic muscle inflammation, pain and weakness.
"Data from an earlier reported placebo-controlled phase-1 study suggested
therapeutic activity with single doses in patients with lupus and demonstrated an acceptable safety profile," said Geoffrey M Nichol, M B Ch B, senior vice president of Product Development at Medarex. "We are very excited about the role of the interferon alpha inflammatory pathway and look forward to exploring its potential in treating patients with lupus and other autoimmune diseases."
MEDI-545 (previously known as MDX-1103) is a fully human monoclonal antibody 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 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.
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases.