Selecta Biosciences Inc. and Swedish Orphan Biovitrum AB unveiled top-line phase III data from the Dissolve I and II trials testing SEL-212 in adults with chronic refractory gout (CRG) – results that position the companies for a regulatory filing in the U.S. during the first half of next year. SEL-212 could take on Horizon Therapeutics plc’s Krystexxa (pegloticase), a pegylated uric acid specific enzyme cleared by the U.S. FDA for CRG in September 2010.
With enrollment set to finish any day in Selecta Biosciences Inc.’s Dissolve II study testing SEL-212 in chronic refractory gout (CRG), investor appetite runs high in the space, as contenders line up to take on Horizon Therapeutics plc’s Krystexxa (pegloticase), the only product approved for CRG.
Selecta Biosciences Inc., of Watertown, Mass., and Stockholm’s Swedish Orphan Biovitrum AB (Sobi) signed a licensing agreement for SEL-212, which is designed to control serum uric acid, reduce immunogenicity and allow for repeated monthly dosing when treating chronic refractory gout.