Omeros Corporation announced preliminary results from the Phase 1 clinical trial of its MASP-3 inhibitor OMS906. The ongoing trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) administration of OMS906 to healthy adult volunteers. OMS906 has been well tolerated at all doses tested. Preliminary human PK and PD data are consistent with once-monthly SC dosing. MASP-3, the key activator of the alternative pathway of complement, converts pro-complement factor D (pro-CFD) to mature CFD. Inhibition of MASP-3 by OMS906 in nonhuman primates reduces systemic levels of mature CFD to below the threshold of detection, correspondingly blocking the alternative pathway of complement. The OMS906 Phase 1 clinical trial design consists of both single- and multiple-ascending dose cohorts. Pharmacodynamic response to OMS906 in the Phase 1 trial is being assessed by quantitation of mature CFD in plasma. In the single-ascending dose stage, 48 subjects have been evaluated to date across a series of IV and SC doses. Findings include: OMS906, administered up to 5 mg/kg, has been well tolerated at all IV and SC doses tested with no apparent safety signals. Single 3 mg/kg IV dose of OMS906 suppresses mature CFD below minimum detectable levels for 4 weeks. Single lowest SC dose of OMS906 suppresses mature CFD at or below minimum detectable levels for 4 weeks. Dose-dependent PK/PD profile across all cohorts is favorable and supports low-dose, once-monthly or less frequent subcutaneous dosing.