Benzinga | Jun 9, 2021 08:47AM EDT

Omeros Announces Preliminary Results From Phase 1 Clinical Trial Of OMS906; Says Results Show Good Safety, PK/PD Profile

Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today 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 The study is ongoing with additional single- and multiple-dose cohorts to determine the pharmacologic dose range and optimal frequency for subcutaneous administration. "The data from the Phase 1 clinical trial to date confirm our expectations for the role and dosing of OMS906 in humans," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The data validate, in humans, the function of MASP-3 -- the key activator of the alternative pathway -- as a regulator of CFD and support the potential of OMS906 as a safe and long-acting therapeutic for the treatment of alternative pathway-related diseases and disorders. Omeros has built a strong intellectual property position around MASP-3 inhibition, and we look forward to completing the current study and advancing to a Phase 2 clinical trial as quickly as possible."