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BRIEF-Omeros says FDA grants breakthrough therapy designation to OMS721 for treatment of IgA Nephropathy
2017年6月13日 / 下午4点06分 / 2 个月前

BRIEF-Omeros says FDA grants breakthrough therapy designation to OMS721 for treatment of IgA Nephropathy

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June 13 (Reuters) - Omeros Corp:

* FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of IgA Nephropathy

* Omeros' second phase 3 clinical program for OMS721 slated to begin this year

* ‍OMS721 is also being evaluated in a phase 3 clinical program for atypical hemolytic uremic syndrome​

* ‍OMS721 also being evaluated in a phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy​

* One or more additional OMS721 phase 3 clinical programs planned to initiate this year in IgA nephropathy, stem cell transplant-associated TMA

* Following discussions with FDA and European Medicines Agency, phase 3 program for OMS721 in atypical hemolytic uremic syndrome is in progress

* Preparing to initiate manufacturing scale-up of its MASP-3 antibodies in advance of clinical trials

* Omeros also expects to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection

* Preliminary clinical evidence indicating that drug may demonstrate "substantial" improvement over existing therapies is required Source text for Eikon: Further company coverage:

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