Anthera Pharmaceuticals, Inc. Announces Positive Outcome of Interim Futility Analysis in the Phase 3 Result Clinical Study of Sollpura
December 11, 2017 at 08:30 am EST
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Anthera Pharmaceuticals, Inc. announced a positive outcome of the pre-specified interim futility analysis for the RESULT Phase 3 clinical study of Sollpura for the treatment of Exocrine Pancreatic Insufficiency (“EPI”). The interim futility analysis was conducted by RESULT’s Data Monitoring Committee which is comprised of experts appointed by the Cystic Fibrosis Foundation’s Therapeutics Development Network. Anthera completed patient recruitment in the RESULT study in November 2017, and based on the interim futility analysis, the study will proceed, as planned, with topline data expected in first quarter of 2018. The RESULT study allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase 3 SOLUTION study. As with current practice with porcine pancreatic enzyme replacement therapies (“PERTs”), the RESULT study allows for dose titrations of Sollpura on an individualized basis to achieve maximum therapeutic benefit. Sollpura has the potential to become the first non-porcine PERT, which may provide a reduction in the size and number of pills patients must consume daily due to the significantly more compact formulation of Sollpura than porcine PERTs.
Anthera Pharmaceuticals, Inc. (Anthera) is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including enzyme replacement therapies and autoimmune diseases. The Company has two Phase III product candidates, liprotamase also known as Sollpura and blisibimod. Sollpura is a non-porcine investigational Pancreatic Enzyme Replacement Therapy (PERT) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI), often seen in patients with cystic fibrosis and other conditions. Blisibimod targets B-cell activating factor (BAFF), which has been shown to be elevated in a range of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE), or lupus, Immunoglobulin A nephropathy (IgA) nephropathy, lupus nephritis and others.