Omeros says statistical significance achieved on key endpoints in Phase 2 trial
Omeros Corporation announced positive data from the company's Phase 2 clinical trial of OMS721 for the treatment of kidney disorders, none of which currently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. Statistical significance was achieved on key endpoints of improvement in renal function. Omeros also reported the outcome of a recent FDA meeting regarding breakthrough therapy designation for OMS721 in immunoglobulin A nephropathy. Based on that meeting, Omeros is pursuing FDA breakthrough therapy designation. In addition to the Phase 2 program in renal diseases, OMS721 is being evaluated in a Phase 3 program for patients with atypical hemolytic uremic syndrome and in a Phase 2 program for patients with thrombotic microangiopathies, including hematopoietic stem cell transplant-associated TMAs and thrombotic thrombocytopenic purpura. OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system. Omeros' Phase 3 OMS721 aHUS program continues to progress with Phase 3 enrollment planned to open late this year. The current TMA Phase 2 clinical trial continues steadily to enroll and treat aHUS patients, gathering data to support a biological license application. Omeros plans to submit aHUS data from this study for presentation at the International Society of Nephrology World Congress of Nephrology in April 2017. The OMS721 program also continues to support compassionate use in Europe and the FDA has approved OMS721 for compassionate use in the U.S.