Teva, Active Biotech reveal Phase IIa study results of oral laquinimod

The study is intended to assess safety, tolerability and efficacy in patients suffering from one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus) that can lead to chronic kidney failure.

The laquinimod treatment showed an additive effect in the development of renal function when combined with the standard of care.

Addenbrooke’s Hospital, Cambridge Vasculitis and Lupus Clinic Principal Investigator 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."

Serious adverse events (AEs) were reported in 12 patients and were to infection, thromboembolic events or lupus-related complications, while reported AEs were comparable in both the active treatment and placebo patient groups.

A death registered in the active treatment arm was not due to the study drug.