Teva Pharmaceutical Industries Ltd. and Active Biotech 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 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.
"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,” said Principal Investigator Dr. David Jayne, Vasculitis and Lupus Clinic, Addenbrooke's Hospital, Cambridge.
“The results from this clinical study further our understanding of how the immunomodulatory profile of laquinimod may benefit patients with lupus,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer of Teva.
“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, NCT01085097, was a multicenter, double-blind, placebo-controlled, exploratory study of 46 patients with active lupus nephritis that evaluated oral laquinimod (0.5 and 1 mg/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 0.5 mg/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 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 study NCT01085097.
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.
Most people who are affected by lupus are women of childbearing age, who suffer from symptoms including intense fatigue and exhaustion, joint pain, thinking and memory problems and skin rashes.
Lupus is two to three times more common among people of African, Hispanic, Caribbean and Asian origin. Many patients fail to respond or respond only partially to the current standard of care treatments.