Omeros' Narsoplimab Associated With Improvement In Organ Function In Stem Cell Transplant Patients

Omeros Corporation OMER has announced the presentation of data on organ function improvement from its pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Data were shared at the European Hematology Association (EHA).
61% of the intent-to-treat (ITT) population (any patient receiving at least one dose of narsoplimab) and 74% of the per-protocol (PP) population (those patients receiving over four weeks of dosing) responded to narsoplimab.
The improvement was based on 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 improved 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.
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.
A marketing application for narsoplimab in HSCT-TMA treatment is under Priority Review by the FDA with an action date of October 17.
Price Action: OMER shares are down 1.08% at $15.64 during the market session on the last check Monday.

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