Late-Stage Lupus Therapies Glow In Halo Of Benlysta Spotlight
This article was originally published in Pharmaceutical Approvals Monthly
If Human Genome Sciences/GlaxoSmithKline’s Benlysta (belimumab) succeeds in becoming the first new lupus therapy in half a century to make it through the regulatory gauntlet, it could change not only the commercial outlook in the lupus market, but also the landscape of future lupus clinical trial design.
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Anthera Pharmaceuticals announced the initiation of PEARL-SC, a 24-week Phase IIb study of the subcutaneous B-cell activating factor inhibitor A-623, that will enroll 600 systemic lupus erthematosus patients worldwide, on July 29. The trial will use a composite efficacy endpoint, the SLE responder index pioneered by Human Genome Sciences' Benlysta (belimumab),which received a special protocol assessment for pivotal lupus trials using the SLE index as the primary endpoint. HGS' BAFF antagonist program, culminating in the June BLA filing of Benlysta, showed the ability of selective B-cell reduction to improve the severity of lupus flares and has been a major contributor to the reinvigoration of lupus R&D (1Pharmaceutical Approvals Monthly, July 2010). Anthera licensed exclusive worldwide rights to A-623, a broader inhibitor of BAFF than Benlysta that inhibits both membrane-bound and soluble B-cell activating factor (also know as BLyS), from Amgen in 2007 and successfully reactivated the IND earlier this summer. The Phase IIb trial will feature three active treatment arms and a placebo arm. Secondary endpoints include safety, improvement in other clinical assessment scores, need for use of steroids and time to flare, the company said. A blinded interim biomarker analysis is on track for the first half of 2011 "to establish the appropriate drug effect on B-cells and potentially remove any arm that is not demonstrating a biologic effect.