FDA Clears Phase II Clinical Trial For Omeros' OMS721 in Thrombotic Microangiopathies
By Cyndi Root
Omeros Corporation announced in a press release that the Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for OMS721. The human monoclonal antibody will be tested in a Phase II trial for thrombotic microangiopathies (TMAs). The FDA gave OMS721 Orphan Drug status last year due to its potential to treat a rare condition. Gregory Demopulos, chairman and CEO of Omeros said, "The FDA's decision clears the way for us to begin the Phase 2 program for OMS721. We are excited by the data in serum samples from aHUS patients, and we look forward to reporting results from our Phase 2 clinical trial in patients with aHUS and other TMAs later this year."
Thrombotic Microangiopathies
Thrombotic microangiopathies (TMAs) are blood vessel disorders inside the organs, usually the brain and the kidney. Normally, endothelial cells form a smooth lining in the capillaries. If the endothelial cells are damaged, the capillary lining is rough, causing blood to slow down. Blood clots form and can block the blood vessels and cut off blood to the kidney. This rare condition is life-threatening or disabling. Optimal treatment is not standardized. Patients are treated with plasma exchange, a drug called rituximab, and kidney dialysis.
OMS721
OMS721 is a monoclonal antibody, a synthetic protein that targets mannan-binding lectin-associated serine protease-2 (MASP-2). The newly approved Phase II trial intends to explore the drug’s action in the lectin pathway — one of the major pathways in the immune system. OMS721 blocks the lectin pathway by inhibiting MASP-2.
Recent results have proved this approach works, suggesting that MASP-2 and the lectin pathway are involved with one TMA, atypical hemolytic uremic syndrome (aHUS). Omeros will begin the trial within the next few months. Investigators will study a few types of TMAs, including stem cell transplant-related TMA, atypical hemolytic uremic syndrome (aHUS), and thrombotic thrombocytopenic purpura (TTP). Omeros owns all the rights to MASP-2 inhibition and it is developing other MASP-2 antibodies. OMS721 is its leading human monoclonal antibody candidate. If approved for marketing, patients can self-administer the drug by injection.
About Omeros
Omeros Corporation is focused on clinical stage drugs in schizophrenia, Huntington's disease, cognitive impairment, addictions, and complications in surgical procedures. The FDA is currently reviewing Omeros’ Omidria (OMS302) for lens replacement surgery.