Omeros Corporation announced positive sensitivity analysis results for narsoplimab, its monoclonal antibody targeting the lectin pathway of complement, in treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). An independent statistical group conducted the analyses, confirming the robustness of previously reported primary endpoint data showing narsoplimab’s survival benefit in TA-TMA patients. The sensitivity analyses consistently demonstrated a significant reduction in mortality risk, with hazard ratios ranging from 0.24 to 0.42 and p-values ranging from less than 0.00001 to 0.0124.
This confirmation of narsoplimab’s efficacy is crucial for patients facing TA-TMA, a life-threatening complication with limited treatment options and high mortality rates. A therapy that demonstrably improves survival could drastically change the prognosis for these patients, potentially reducing long-term complications and improving quality of life. This also represents a critical step towards addressing an unmet medical need in the post-transplant setting.
The independent analysis considered various factors, including different time points (100 days, 1 year, 2 years) and risk factor stratification. Despite these variations, the analyses consistently revealed narsoplimab’s positive impact on survival, underscoring the reliability of the initial findings. The original primary endpoint analysis, reported in December 2024, showed a hazard ratio of 0.32, indicating a more than three-fold reduction in mortality risk for narsoplimab-treated patients compared to the control group. The new data strengthens these conclusions.
Omeros anticipates further analyses incorporating data from their expanded access program, expected soon. The company is moving forward with plans to resubmit a Biologics License Application (BLA) to the FDA later this quarter and a European Marketing Authorization Application (MAA) by mid-year 2025. These positive results pave the way for potential regulatory approval and the introduction of a much-needed treatment for TA-TMA, offering a new hope for patients undergoing hematopoietic stem cell transplantation.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
