Expert Panel Points to Central Role of Endothelial Injury and Lectin Pathway Activation in Critically Ill COVID-19 Patients
- Omeros’ investigational agent narsoplimab discussed as a potentially highly effective therapy -
The panel discussed the emerging evidence that endothelial injury and the activation of the lectin pathway of complement are central drivers of the acute respiratory distress syndrome (ARDS) and thrombosis seen in critically ill COVID-19 patients. Narsoplimab, Omeros’ investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key effector of the lectin pathway of complement, was identified as a potentially highly effective therapy to treat critically ill COVID-19 patients.
Omeros previously announced positive results from the treatment with narsoplimab of six critically ill COVID-19 patients under a compassionate use protocol. All patients initially required mechanical ventilation and, following treatment with narsoplimab, all recovered, survived and were discharged from the hospital.
Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.
Phase 3 clinical programs are in progress for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), in immunoglobulin A (IgA) nephropathy, and in atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company’s lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the
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