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FDA signs off on Phase 3 protocol for Omeros' OMS721 in IgA nephropathy; shares up 9%

Published 01/03/2018, 10:08 AM
© Reuters.  FDA signs off on Phase 3 protocol for Omeros' OMS721 in IgA nephropathy; shares up 9%
OMER
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  • Omeros (OMER +8.7%) has reached agreement with the FDA on the design of a Phase 3 clinical trial assessing OMS721 in patients with IgA nephropathy (IgAN).
  • The randomized, double-blind, placebo-controlled study will enroll adult patients with biopsy-confirmed IgAN and 24-hour urine protein excretion greater than 1 g/day at baseline. The primary endpoint is the reduction in proteinuria at week 24. The study should launch next month.
  • Orphan Drug- and Breakthrough Therapy-tagged OMS721 binds to an enzyme called mannan-binding lectin-associated serine protease-2 (MASP-2) which plays a key role in the lectin pathway of the complement system, which is believed to contribute to significant tissue injury.
  • Previously: Omeros' OMS721 continues to demonstrate treatment benefit after one year in IgA nephropathy patients; shares ahead 5% (Aug. 14, 2017)
  • Now read: Omeros Corporation - Highly Promising Prospects


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