7:34AM Omeros announces positive data in Phase 1 clinical trial with OMS721; Phase 2 program expected to begin enrollment next quarter (OMER) 9.14 : Co announced positive clinical data in a Phase 1 clinical trial of OMS721, the co's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), an important regulator of the lectin pathway of the immune system. Subcutaneous administration of OMS721 achieved a high degree of lectin pathway inhibition. The drug was well tolerated and no drug-related adverse events were observed. A Phase 2 clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), a family of disorders that occurs in the microcirculation of the body's organs, most commonly the kidney and brain, is expected to begin enrollment in early 2014.
To date, four cohorts of subjects have received OMS721 or placebo by subcutaneous injection at increasing dose levels. OMS721 or placebo injections were well tolerated in all subjects. No clinically significant abnormalities on laboratory tests or electrocardiograms have been observed. At the highest subcutaneous dose administered to date, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase 1 subjects are similar to those associated with efficacy in animal models of diseases linked to the lectin pathway, including those of TMA and neovascular age-related macular degeneration (AMD), a leading cause of vision loss in individuals over 60 years of age.
7:20AM Omeros misses by $0.02, beats on revs (OMER) 9.14 : Reports Q3 (Sep) loss of $0.46 per share, $0.02 worse than the Capital IQ Consensus Estimate of ($0.44); revenues fell 85.7% year/year to $0.2 mln vs the $0.14 mln consensus.
"For OMS302, the marketing applications were accepted for review by both the FDA and EMA, and the market launch is planned for the second half of 2014. Our OMS824 program for the treatment of cognitive disorders was granted orphan drug designation by the FDA, generated positive Phase 1 clinical trial results, began enrollment in a Phase 2 trial in patients with schizophrenia and is now initiating a Phase 2 trial in Huntington's disease. OMS721, our MASP-2 inhibitor, entered a Phase 1 clinical trial from which we reported positive data today, and a Phase 2 trial to evaluate the molecule's efficacy and safety in patients with thrombotic microangiopathies is planned for early 2014. Preclinically, our GPCR platform continued to identify functionally active compounds against an unprecedented number of orphan receptors, and our addiction and high-risk bleeding programs advanced toward the clinic. Following the close of the quarter, we added over $17 million to our balance sheet, positioning Omeros to execute on a series of value-driving milestones during the remainder of 2013 and well into 2014."
