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Omeros Corporation Reports Updated Results from Narsoplimab HSCT-TMA Clinical Trial and Highlights from Recent Clinical and CMC Meetings with FDA
– Results Surpass FDA-Agreed Efficacy Threshold – SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today reports an update on clinical data from
About this update from Omeros Corporation
[{"type":"text","content":"\n– Results Surpass FDA-Agreed Efficacy Threshold –\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today reports an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. While an overview of preliminary data submitted to FDA was made public on December 4, 2019 in a press release from the company, all patients have now completed treatment and trial enrollment has been closed. Narsoplimab is Omeros’ human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).\n\n\nIn recent meetings with FDA focused on clinical as well as chemistry, manufacturing and controls (CMC) data, FDA confirmed important aspects of Omeros’ rolling Biologics License Application (BLA) for narsoplimab in HSCT-TMA. The BLA continues on its clear path to completion.\n\n\nThe efficacy threshold agreed with FDA, the updated results from the 28-patient trial, and highlights of the recent FDA meetings are the following:\n\n\nPrimary Endpoint\n\n\n\n15% is the FDA-agreed efficacy threshold for the primary endpoint (i.e., the complete response rate [CRR]) in the clinical trial\n\n\nThe CRR for the study population, and the lower limit of the 95 percent confidence interval (95% CI), significantly exceed the efficacy threshold:\n\n\n54 percent CRR (95% CI = 34 percent to 72 percent, p-value \n\n65 percent CRR (95% CI = 43 percent to 84, p-value \n\n\n\nAs described in the December 4, 2019 press release, the FDA-agreed primary endpoint (the CRR) is the proportion of patients who fully achieve a rigorous set of response criteria, requiring both improvement in HSCT-TMA laboratory markers (platelet count and lactate dehydrogenase [LDH] levels) and improvement in clinical status comprised of organ (renal, pulmonary, gastrointestinal and neurological) function and transfusions (platelet and red blood cells). The full response criteria are provided below.\n\n\n\nSecondary Endpoints\n\n\n\nThe 100-day survival (defined as survival from the day of HSCT-TMA diagnosis) is 68 percent in all treated patients, 83 percent in patients who received at least 4 weeks of narsoplimab treatment as specified by the protocol, and 93 percent in patient...