GSK announces start of Phase III study for vasculitis drug candidate

GlaxoSmithKline, a research-based pharmaceutical and healthcare company, announced on Wednesday the beginning of a Phase III study to evaluate Benlysta, a drug candidate to treat vasculitis.

The multi-national, multi-center, double-blind, randomized study will evaluate the safety and efficacy of Benlysta, also known as belimumab, when combined with azathioprine. The study will test the drug combination for the maintenance of remission in patients with anti-neutrophil cytoplasmic antibodies positive vasculitis, a condition that involves inflamed blood vessels.

Vasculitis is a condition where the human immune system attacks blood vessels and causes the vessels to become inflamed. The condition leads to the disruption of blood flow and can damage organs. The signs and symptoms of vasculitis vary depending on the extent of the damage and which organs sustain damage.

ANCA-associated vasculitis is the most primary systemic small-vessel vasculitis to occur in adults.

Belimumab is the first in a drug class known as BLyS-specific inhibitors. In 2011, the drug was approved by the U.S. Food and Drug Administration to treat adult patients with active, autoantibody-positive systemic lupus erythematosus who receive standard therapy. The drug was approved by the European Commission in 2011 as add-on therapy in adult patients with active, autoantibody-positive SLE with a high degree of disease activity despite employing standard treatment.

Belimumab has yet to receive approval for use for vasculitic disease.