European Regulatory Authority approves compassionate use of OMS721 in two patients with thrombotic microangiopathy

The European Regulatory Authority has approved Omeros’ investigational product, OMS721, for compassionate use.

OMS721 is Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS). TMAs are a family of rare, debilitating and life-threatening disorders characterised by excessive thrombi (clots) in the microcirculation of the body’s organs, most commonly the kidney and brain.

Compassionate-use study approval based on improvements shown during Phase 2 clinical trial of OMS721

The two patients in the compassionate-use study suffer from aHUS and were enrolled in the first cohort of the Phase 2 clinical trial. Based on improvements across markers of disease activity in that cohort, the investigator requested that Omeros continue to provide OMS721 so that the patients could extend their treatments.

Omeros’ ongoing OMS721 Phase 2 study continues to progress through its dose-ranging phase. The second cohort of patients, which received a higher dose than the first cohort, has now completed treatment. Following a pre-planned data review by internal and external physicians, if the safety data from the second cohort are acceptable, a recommendation will be made to advance as scheduled to a third cohort at an even higher dose. This third cohort could begin dosing before the end of April.

“We are pleased to extend OMS721 treatment for patients suffering with TMAs beyond the initial planned duration of the Phase 2 study,” stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros. “We are excited by the progress our OMS721 Phase 2 program and look forward to its continued advancement following the second-cohort data review.”

For more information about Omeros, please visit www.omeros.com.