Anthera to conduct phase 3 study of blisibimod for SLE

Anthera Pharmaceuticals announced that it is recruiting patients with higher levels of systemic lupus erythematosus disease activity for its phase 3 study of blisibimod treatment.

The recruitment will be held at 31 sites across 11 countries in Eastern Europe, Latin America and Southeast Asia, according to a press release that included Anthera’s 2013 fiscal year financial results. The trial of patients with higher levels of disease activity and positive lupus serology despite corticosteroid therapy will serve as a registration study for systemic lupus erythematosus (SLE) indication and include safety data in a potential immunoglobulin A nephropathy marketing application for blisibimod.

Anthera also intends to submit a second lupus study to the FDA in the first quarter, after recent input from the FDA and key opinion leaders, according to the release. The study will enroll patients with active lupus, including patients with glomerulonephritis and who recently might have been diagnosed with lupus nephritis.

The primary endpoints of both studies are similar and intended to reflect SLE Response Index-8 (SRI-8).

“These two pivotal studies may form the basis of approval for blisibimod as a treatment for patients with lupus,” the release stated.

Anthera reported net fourth-quarter and 2013 annual losses of $9.2 million and $30.9 million, respectively, according to the release.