Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Active Biotech (Nasdaq: OMX NORDIC: ACTI) today announced the results of a Phase IIa study of oral Laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis. This is one of the most serious manifestations of lupus that can lead to chronic kidney failure.
The trial found that treatment with Laquinimod provides 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.
Cambridge UK's Addenbrooke's Hospital Vasculitis and Lupus Clinic principal investigator Dr. David Jayne said, "The favorable trends towards laquinimod treatment in the renal end-points, coupled with the safety and tolerability profile, provide a rationale for further Phase III clinical studies."
Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, “The results from this clinical study further our understanding of how the immunomodulatory profile of Laquinimod may benefit patients with lupus. The development program for Laquinimod, which also includes clinical studies for other autoimmune disorders like multiple sclerosis, and Crohn's disease, underscores Teva’s continued commitment to bringing innovative and differentiated medicines to improve patients' lives.”
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. 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 were comparable in both the active treatment and placebo patient groups. Serious events 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 and sepsis in a patient with advanced disease. The death was not attributed to the study drug.
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 the completed study.
Lupus is a chronic and often disabling autoimmune disease. An estimated five million people worldwide, including 1.5 million Americans, have a form of lupus.
Published by Globes [online], Israel business news - www.globes-online.com - on June 12, 2013
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