Date: 2013-06-12
Type of information:
phase: 2a
Announcement: presentation of results at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, 12-15 June, 2013
Company: Active Biotech (Sweden) Teva Pharmaceuticals (Israel)
Product: laquinimod
Action mechanism: Laquinimod is an oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting multiple sclerosis (MS). Laquinimod showed efficacy in animal models for both MS and Lupus Nephritis. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
Disease: active lupus nephritis
Therapeutic area: Autoimmune diseases
Country: USA, Canada, France, Russian Federation, UK
Trial
details: The clinical trial, , 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. (NCT01085097)
Latest
news: * On June 12, 2013, Teva Pharmaceutical Industries and Active Biotech have announced today the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus) that can lead to chronic kidney failure. Treatment with laquinimod provided an additive effect in improving renal function when combined with current standard of care for active lupus nephritis (mycophenolate mofetil and corticosteroids), compared with standard of care alone. The study showed that at 24 weeks, 62.5% of patients with active lupus nephritis who received 0.5mg/day of laquinimod achieved renal response, compared to 33.3% of patients who were administered placebo. Renal response is a composite end point that measures several parameters of renal improvement. Reported adverse events (AEs) were comparable in both the active treatment and placebo patient groups. Serious AEs were reported in 12 patients (four in each treatment group) and were attributed to infection, thromboembolic events or lupus-related complications. One death occurred in the active treatment arm due to pan-lobar pneumonia & sepsis in a patient with advanced disease. The death was not attributed to the study drug.Laquinimod has been developed for the treatment of relapsing-remitting multiple sclerosis. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
