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Omeros Reports Positive Data Across Primary and Secondary Endpoints in Pivotal Trial of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy Patients Treated with Narsoplimab
– 56 Percent of All Narsoplimab-Treated Patients Were Complete Responders by Primary Endpoint, Achieving Full Set of Response Criteria Agreed by FDA; 68
About this update from Omeros Corporation
[{"type":"text","content":"\n– 56 Percent of All Narsoplimab-Treated Patients Were Complete Responders by Primary Endpoint, Achieving Full Set of Response Criteria Agreed by FDA; 68 Percent Primary-Endpoint Complete Response Rate for Those Who Received Protocol-Specified Treatment of At Least 4 Weeks of Dosing –\n\n\n– 100-Day Survival Across All Narsoplimab-Treated Patients Was 65 Percent; 93 Percent for Complete Responders –\n\n\n– Statistically Significant (p \n\n– No Signal of Any Serious Safety Risk Observed in the Trial; Adverse Events Comparable to Those Commonly Seen in Stem-Cell Transplant –\n\n\n– Conference Call and Webcast Today at 8:30 a.m. EST –\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today announced positive data from its pivotal clinical trial of the company’s novel investigational complement inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a frequently lethal complication of HSCT. These preliminary data were recently provided to FDA as part of the company’s ongoing interactions with the Agency on the narsoplimab Biologics License Application (BLA). All safety and efficacy endpoints – including the composite primary endpoint and the secondary endpoints – are agreed with FDA. The reported data support a strongly positive benefit-risk balance.\n\n\nThe primary efficacy endpoint in this single-arm open-label trial of HSCT-TMA patients is the proportion of patients who achieve a highly rigorous set of response criteria that requires both improvement in HSCT-TMA laboratory markers and improvement in clinical status (organ function and transfusions). Patients who did not fully meet these criteria were considered non-responders. The secondary endpoints include survival rates and change from baseline in HSCT-TMA laboratory markers. Consistent with the pre-specified statistical analysis plan for the trial, the primary and secondary endpoints are assessed for (1) all patients who received at least one dose of narsoplimab and (2) patients who received at least 4 weeks of narsoplimab dosing. Patients enrolled in this trial had a high expected mortality rate. In severe cases of HSCT-TMA, mortality can exceed 90 percent.\n\n\nPrimary Efficacy Endpoint:\n\n\n\n56 percent of all patients receiving at least one dose of narsoplimab achieved complete respo...