Feb. 3, 2014
/PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced positive data following completion of dosing in a Phase 1 clinical trial of OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (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. Omeros expects to initiate a Phase 2 clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), 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.
This 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 previously reported interim Phase 1 clinical 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. At the highest dose evaluated, both subcutaneous and intravenous routes of administration resulted in a high degree of inhibition of lectin pathway and successfully achieved the pharmacologic target of sustained inhibition for at least one week. The positive results in the Phase 1 trial enable selection of the dose levels to be evaluated in the Phase 2 program, which will assess the safety and efficacy of OMS721 in patients with disorders thought to involve lectin pathway activation, including TMAs.
Omeros previously reported positive data using OMS721 both in a well-established model of TMA and in a well-established model of age-related macular degeneration (AMD). Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2. MASP-2 is critical to the function of the lectin pathway, one of the principal components of the complement system, a key part of the immune response.