Omeros : OMS906 Phase 1 Trial Results Show PK/PD Consistent With Low-dose, Once-monthly SC Dosing
(RTTNews) – Omeros Corp. (OMER) 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 pharmacokinetics and pharmacodynamics data are consistent with once-monthly subcutaneous dosing.
According to the preliminary results, 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.