Omeros To Begin Phase 2 Trials In TMA Next Quarter

Omeros Corporation announced that it has submitted an investigational new drug application to the U.S. Food and Drug Administration (FDA) to initiate a Phase II trial for OMS721 in patients with thrombotic microangiopathy (TMA) and those with atypical hemolytic uremic syndrome (aHUS).

The application is based on positive results for OMS721 on ex vivo studies of endothelial activation associated with the pathophysiology of aHUS and TMA. The investigative antibody significantly inhibited complement deposition in the trial model using serum samples from patients with aHUS which were obtained during the acute of their disease and during remission, compared to untreated controls.

Professor Giuseppe Remuzzi, Research Coordinator at the Mario Negri Institute for Pharmacological Research in Bergamo, Italy, said “The OMS721 data in serum samples from aHUS patients are of great interest even in relation to disease pathophysiology.” Professor Giuseppe is also an international expert in the study of kidney disease and has made major contributions advancing the understanding of the pathophysiology of hemolytic uremic syndrome.

OMS721 is the lead human monoclonal antibody in mannan-binding lectin-associated serine protease-2 (MASP-2) program. MASP-2 is a novel pro-inflammatory protein target which plays a crucial part in activation of the complement system, a crucial immune system component.

Thrombotic microangiopathy is a family of rare, debilitating, and life-threatening diseases. TMAs are characterized by multiple clots in the microcirculation of the body’s organs especially the kidney and the brain.

Gregory A. Demopulos, chairman and chief executive officer of Omeros, said “We are excited by the performance of OMS721 in serum samples from aHUS patients. These data indicate that the lectin pathway and MASP-2 specifically, are involved in the pathophysiology of aHUS, one of the devastating TMAs. We look forward to initiating enrollment next quarter in our OMS721 Phase 2 trial in patients with aHUS and other TMAs, and we hope to be able to share the results later this year.”