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Anthera Announces the Advancement of Blisibimod into Phase 3 Development for Patients with Systemic Lupus Erythematosus (SLE)
Date:9/17/2012

ematosus Response Index (SRI*) including the requirement of an eight-point or greater improvement from baseline in the SELENA/SLEDAI disease measurement (SRI-8).

"The use of an SRI-8 endpoint, in a population with higher baseline disease activity requires patients to demonstrate improvement in the clinical presentations of SLE, such as skin, mucosal, joint disease and kidney disease," said Colin Hislop, Anthera's Chief Medical Officer.  "For example, the blisibimod 200 mg weekly dose reduced proteinuria by nearly 1 gram per 24 hours at Week 24 compared with minimal change in the placebo group.  This corresponds to an approximate 50% decrease from baseline. These types of improvements were responsible for the majority of clinical benefits seen in the PEARL-SC study and highlights blisibimod's potential to help patients with more active disease."

As previously reported, results from the PEARL-SC study indicate that in the predefined population of patients with clinically active disease (SELENA-SLEDAI > 10) who were also taking corticosteroids, the SRI-8 treatment benefit in the 200 mg weekly blisibimod cohort was statistically significant at week eight (22.6% blisibimod response versus 6.4% placebo response, p=0.023) and at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001). Results from the PEARL-SC clinical study have been submitted to the American College of Rheumatology for presentation at the ACR/ARHP Annual Scientific Meeting 2012 in Washington, D.C.

*SRI is defined as patients who respond to treatment and achieve a reduction in SELENA-SLEDAI equal to or greater than the number indicated, no new BILAG A or two B organ domain scores, and no increase in Physician's Global Assessment (PGA) of greater than 0.3 on a three point scale.

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