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.
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.
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.