Biopharmaceutical company Anthera Pharmaceuticals has commenced a Phase III study of blisibimod to treat systemic lupus erythematosus (lupus).

Blisibimod is a novel inhibitor of B-cell activating factor (BAFF), being developed as a treatment for chronic autoimmune disease systemic lupus erythematosus.

Anthera chief medical officer Dr Colin Hislop said the Phase IIb study results indicate the possibility of blisibimod becoming a highly effective treatment option for the more severely ill lupus patients, compared to existing therapeutics.

"We are excited to advance blisibimod’s development. Today we have taken another step towards making a much needed treatment available for this unpredictable and devastating disease," Hislop said.

"Blisibimod is a novel inhibitor of B-cell activating factor (BAFF), being developed as a treatment for chronic autoimmune disease systemic lupus erythematosus."

Approximately 400 patients from Latin America, Asia Pacific and the Commonwealth of Independent States with clinically active SLE (SELENA-SLEDAI > 10) who have not achieved optimal resolution of their disease with corticosteroid use will be enrolled in the double-blind study.

The multicentre, placebo-controlled, randomised study will assess the efficacy, safety, tolerability and immunogenicity of blisibimod.

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The patients will be randomised with blisibimod or placebo for 52 weeks, after which they will have the option to receive blisibimod therapy in an open-label, long-term, follow-up safety study.

The pimary endpoint will be a systemic lupus erythematosus response index-8 (SRI-8), defined as a patient who has achieved a reduction in SELENA-SLEDAI equal to or greater than eight points, no new BILAG A or two B organ domain scores and no increase in Physician’s Global Assessment of greater than 0.3 on a three point scale.

A summary of interim analyses is expected later in 2013.