Teva Pharmaceutical Industries Ltd.,(TEVA) and Active Biotech (ATVBF.PK) Wednesday announced results of a Phase IIa study of oral laquinimod that provided an additive effect in improving renal function in patients with active lupus nephritis when combined with current standard of care for active lupus nephritis (mycophenolate mofetil and corticosteroids), compared with standard of care alone.
Active lupus nephritis is one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus) that can lead to chronic kidney failure. The study was designed to assess safety, tolerability and clinical efficacy in the patients.
The clinical trial, NCT01085097, was a multicenter, double-blind, placebo-controlled, exploratory study of 46 patients with active lupus nephritis that evaluated oral laquinimod (0.5 and 1mg/day) versus placebo in combination with standard of care treatment. The company said the data will be presented during the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, 12-15 June, 2013 as part of the late-breaking news session.
A larger clinical trial of laquinimod in combination with standard of care (mycophenolate mofetil and corticosteroids), compared to standard of care alone, is planned in patients with lupus nephritis to further evaluate the safety and efficacy profile observed in study NCT01085097.
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