Omeros Reports Positive Data After Dosing In Phase 1 Trial With OMS721

(RTTNews) - Omeros Corp. (OMER) announced positive data following completion of dosing in a Phase 1 study of OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 or MASP-2, the key regulator of the lectin pathway of the immune system. OMS721, administered either by subcutaneous injection or intravenous infusion, was well tolerated and achieved the objective of a high degree of sustained lectin pathway inhibition. The company expects to begin a Phase 2 program to assess OMS721 in the thrombotic microangiopathies or TMAs treatment, a family of orphan disorders, including atypical hemolytic uremic syndrome, that occurs in the microcirculation of the body's organs, most commonly the kidney and brain, later this quarter.

The Phase 1 trial is a placebo-controlled, double-blind, single-ascending-dose study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 in healthy subjects. Seven cohorts of subjects received OMS721 or placebo by either subcutaneous injection or intravenous infusion at increasing dose levels. Consistent with the prior reported interim Phase 1 data, OMS721 administration was well tolerated in all subjects, there were no drug-related adverse events, and no clinically significant abnormalities on laboratory tests or electrocardiograms have been observed.

The positive results in the Phase 1 study enable selection of the dose levels to be assessed in the Phase 2 program, which would evaluate the safety and efficacy of OMS721 in patients with disorders thought to involve lectin pathway activation, including TMAs.

Earlier, the company reported positive data using OMS721 both in a well-established model of TMA and in a well-established model of age-related macular degeneration.