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ARTICLE | Clinical News

OMS721: Phase II data

August 24, 2015 7:00 AM UTC

Data from 3 patients in the mid-dose cohort and 1 patient in the high-dose cohort of an open-label, international Phase II trial showed that OMS721 for 4 weeks was well tolerated. In the mid-dose cohort, 2 patients have atypical hemolytic uremic syndrome (aHUS) and were on renal dialysis prior to and at the time of enrollment and 1 patient has thrombocytopenic purpura ( TTP). The patient in the high-dose cohort has aHUS. All 3 aHUS patients receiving mid- or high-dose OMS721 had a significant mean increase of about 68,000 platelets/mL from baseline to week 4, the primary endpoint (p=0.0055). In the 2 plasma therapy-resistant aHUS patients in the mid-dose cohort, OMS721 led to a 47% mean increase in platelet count; an 86% mean reduction in schistocyte count, with schistocytes disappearing in 1 patient; a 71% mean increase in mean haptoglobin levels; and a 5% reduction in the mean LDH levels. The TTP patient in the mid-dose cohort required repeated plasma infusion therapy prior to treatment with OMS721, but did not require plasma therapy during the trial and has not required it since completing treatment with OMS721. ...