MedImmune has begun dosing lupus patients in a Phase I clinical trial to evaluate the safety and tolerability of MEDI-545, its monoclonal antibody (MAb) targeting interferon-alpha. The MAb is being developed for the potential treatment of patients with systemic lupus erythematosus (SLE or lupus).
The study is a randomized, double-blind, placebo-controlled, dose-escalation trial involving a single intravenous dose of the anti-interferon-alpha antibody in patients who have mild SLE with lupus rash or skin lesions. Forty-five individuals will be enrolled at approximately 20 centers in North America.
MEDI-545 is a fully human monoclonal antibody (MAb) targeting interferon-alpha. Preclinical data indicate that levels of interferon-alpha are elevated in many patients with active systemic lupus erythematosus (SLE or lupus) 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.