9/17/2023 0 Comments Omeros corporation news![]() ![]() "The effect of OMS906 in PNH, a disease that requires a high level of alternative pathway suppression to see clinical benefit, bodes well for the drug’s role in treating any disorder associated with dysregulation of the pathway. "These trial data are quite impressive," said Eleni Gavriilaki, M.D., Ph.D., assistant professor of hematology at Aristotle University, Thessaloniki, Greece. This dosing frequency and the extended OMS906 half-life should provide excellent patient convenience and compliance as well as additional protection from pharmacokinetic or pharmacodynamic breakthrough, further enhancing efficacy. Inhibition of MASP-3, which is located upstream of complement component 5 (C5), C3, Factor B and Factor D, is expected to block both intra- and extravascular hemolysis in PNH.īased on pharmacokinetic data in both healthy subjects and patients with PNH and the efficacy data observed in PNH patients, Omeros is targeting a dosing frequency of once quarterly either intravenously or subcutaneously. Unlike other alternative and terminal complement pathway inhibitors on the market or in development, MASP-3 inhibition leaves the infection-fighting function of the classical pathway intact and, given that MASP-3 is known not to be an acute phase reactant, has less risk of breakthrough occurrence of the underlying disease. MASP-3 circulates in low concentrations and has slow turnover, allowing consistent and long-duration target coverage and pathway inhibition. OMS906 is Omeros’ lead investigational humanized monoclonal antibody targeting MASP-3, the key and most upstream activator of the alternative pathway of complement. Omeros has established a broad intellectual property estate directed to the inhibition of MASP-3. ![]() To date, 7 patients have received 2 or more doses of OMS906, 4 have received 3 or more doses, and 3 have received 4 doses. ![]() Co-existing conditions in these 9 patients include aplastic anemia, iron deficiency, myelodysplastic syndrome, and chronic renal failure. A total of 9 patients have been enrolled to date and all have been complement-inhibitor-treatment naïve. This single-arm, open-label clinical trial is evaluating the effect of once-monthly subcutaneous administration of OMS906 in patients with PNH. To date, all patients have received only the lowest subcutaneous dose of OMS906 in this multidose trial. Statistically significant and clinically meaningful improvements were observed in all measured markers of hemolysis, including hemoglobin (Hgb) and lactate dehydrogenase (LDH). SEATTLE, April 25, 2023-( BUSINESS WIRE)-Omeros Corporation (Nasdaq: OMER) today announced positive results from a pre-specified interim analysis of its ongoing Phase 1b clinical trial of OMS906, the company’s lead MASP-3 inhibitor, in complement-inhibitor-naïve adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening hemolytic blood disorder. OMS906 was well tolerated with no safety signals of concern At lowest planned subcutaneous dose, Omeros’ MASP-3 inhibitor OMS906 showed clinically and statistically significant improvements in hemoglobin and LDH, which were seen early and maintained throughout the observation periodįollowing 2 doses of OMS906, all patients achieved an increase in hemoglobin of ³ 4.0 g/dL, with a mean hemoglobin change from baseline of 4.75 g/dL (p < 0.001)įollowing 3 doses of OMS906, mean hemoglobin increase from baseline was 6.27 g/dL (p = 0.005)Īll OMS906-treated patients remained transfusion-free throughout the observation period ![]()
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