Benzinga | Jun 14, 2021 08:32AM EDT

Omeros Highlights Presentation Of Narsoplimab Pivotal Trial Data In Oral Presentation At 2021 Annual Congress Of European Hematology Association

Data on Organ Function Improvement Presented by Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering --

Omeros Corporation (NASDAQ:OMER) today announced that data on organ function improvement from its pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 26th Congress of the European Hematology Association (EHA). The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy, was delivered last Friday by Miguel-Angel Perales, M.D., Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center. The organ function improvement data presented underscore the potential of narsoplimab as a significant advance in the treatment of often fatal HSCT-TMA.

The trial's findings include:

* The study population was high-risk, with 93 percent having multiple risk factors for poor outcomes, and highly reflective of "real-world" clinical practice

* At baseline: 75% of patients had kidney dysfunction 57% had neurologic dysfunction 18% had pulmonary dysfunction 50% had multiple organ TMA involvement 86% had significant infection 68% had graft versus host disease (GVHD) 61% of the intent-to-treat (ITT) population (any patient receiving at least 1 dose of narsoplimab) and 74% of the per-protocol (PP) population (those patients receiving ? 4 weeks of dosing) responded to narsoplimab based on improvement in laboratory TMA markers (platelet count improvement and reduction in LDH levels) and clinical status (organ function or freedom from transfusion) 74% of eligible patients in the ITT population experienced improvement in organ function (67%, 50% and 100% in kidney, neurologic, or gastrointestinal function, respectively); 77% of eligible patients in the PP population experienced organ function improvement 48% of eligible patients in the ITT population and 55% in the PP population experienced freedom from transfusion Narsoplimab was well tolerated in this very sick population The most common adverse events were pyrexia, diarrhea, vomiting, nausea, neutropenia, fatigue, and hypokalemia, all common in HSCT Six patients died during the core study period due to causes common in HSCT There were no study discontinuations due to non-fatal adverse events Detailed data and findings from the study are being submitted to a peer-reviewed scientific journal for publication. Dr. Perales' question-and-answer panel discussion for his presentation is scheduled for Tuesday, June 15, at 1:00-1:45 pm CEST/7:00-7:45 am EDT and will be available to registered attendees through the EHA Congress virtual platform. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, significant morbidity is common with chronic organ injury often persisting. There is no approved treatment for HSCT-TMA. A Biologics License Application for use of narsoplimab in the treatment of HSCT-TMA is under Priority Review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act action date of October 17, 2021.