Omeros’ OMS906 Data Presented at Complement-based Drug Development Summit
Believed to be the premier target in the alternative pathway, MASP-3 is responsible for the conversion of pro-complement factor D to mature complement factor D (CFD), and OMS906 is designed to block that conversion. The presentation included data demonstrating that a single dose of OMS906 in an animal study demonstrated a decrease of mature CFD and an increase and accumulation in pro-CFD levels that remained detectable for more than three weeks. Data also showed that lowest levels of detectable mature CFD correlated with complete inactivation of the alternative pathway.
Omeros expects OMS906 to have broad application in conditions involving inflammation and tissue damage as well as disorders associated with dysregulation of the alternative pathway. Paroxysmal nocturnal hemoglobinuria (PNH) is targeted as the initial indication, and OMS906 has shown greater potency compared to C5 and C3 inhibitors in PNH models. OMS906, by leaving intact the adaptive immune effector function of complement, is also expected to have a more favorable safety profile than C5 and C3 inhibitors.
The targeted OMS906 long-term dosing regimen is once monthly subcutaneous administration. A Phase 1, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose study of OMS906 began dosing subjects last month.
OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system’s alternative pathway. The complement system plays a central role in inflammation and becomes activated as a result of tissue damage or microbial infection. Responsible for the conversion of pro-complement factor D to complement factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders. Through its growing intellectual property position, Omeros controls the use of MASP-3 inhibitors across a wide range of alternative pathway-related and other diseases and disorders.
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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