ANTH's Blisibimod Enters Phase III
Anthera Pharmaceuticals Inc. (ANTH) recently initiated the CHABLIS-SC1 phase III study on blisibimod. Blisibimod is being developed for treating patients suffering from systemic lupus erythematosus (:SLE), a chronic autoimmune disease that can result in severe skin rash, fatigue, joint pain and major organ complications.
Anthera Pharma will enrol around 400 patients for the study from Latin America, Asia Pacific and Commonwealth of Independent States. The patients will be randomized to receive blisibimod or placebo for a period of 52 weeks. Subsequently they will have the option to be treated with blisibimod in an open-label, long-term, follow-up safety study.
We note that Anthera Pharma moved blisibimod into phase III studies following the encouraging results of the candidate in a phase II study (PEARL-SC) and its discussions with the FDA last year. The PEARL-SC study evaluated the efficacy and safety of subcutaneous blisibimod in patients suffering from active and seropositive lupus.
We note that GlaxoSmithKline’s (GSK) Benlysta is already approved for the treatment of SLE.
Further, Anthera Pharma is also developing blisibimod for an orphan indication. The company plans to initiate a phase IIb study on blisibimod in patients suffering from B-cell mediated autoimmune diseases such as IgA nephropathy (Berger’s disease) later this year.
Anthera Pharma, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). However other biopharma stocks such as Cytokinetics Inc. (CYTK) and Array BioPharma Inc. (ARRY) currently look better positioned. While Cytokinetics carries a Zacks Rank #1 (Strong Buy), Array carries a Zacks Rank #2 (Buy).
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