Blisibimod is a selective antagonist of B-cell activating factor (BAFF)/B lymphocyte stimulator (BLyS) that is in Phase III development for SLE. Elevated levels of BAFF have also been associated with several B-cell-mediated autoimmune diseases including lupus nephritis and multiple sclerosis. In January 2008, Anthera Pharmaceuticals announced that it had entered into a license agreement with Amgen for the exclusive and worldwide rights to develop and commercialize blisibimod for the treatment of SLE and other autoimmune diseases.
Thus far, blisibimod (Anthera Pharmaceuticals/Amgen) has only demonstrated moderate clinical efficacy in the early stages of its Phase II trial. Given that the primary endpoint was not met for either of the two lower-dosage groups, the drug will need to demonstrate strong positive results in the long term and in Phase III in order to progress. Furthermore, the Phase III program is focused on targeting only the more severe group of systemic lupus erythematosus (SLE) patients, which could ultimately be a disadvantage for the drug and could limit uptake.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 blisibimod : Systemic lupus erythematosus
LIST OF FIGURES
7 Figure 1: Phase IIb PEARL trial design for blisibimod
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