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. OMS906 has been safe and well tolerated in this trial, consistent with Phase 1 safety observations in healthy subjects. Statistically significant improvements in LDH were observed at Day 8, the first measured timepoint, with subsequent further and statistically significant reductions seen throughout the observation period. The mean baseline LDH was 1931, nearly 8 times the upper limit of normal. Figure 1 demonstrates the Hgb improvement. No patients required or received blood transfusions following OMS906 treatment initiation. Improvement was rapid, with significant mean Hgb improvement of 0.88 g/dL (p = 0.003) seen at the first timepoint (Day 8), persistently increasing and remaining statistically significant through the last observed timepoint (Day 85). By Day 85 (following 3 doses), the mean Hgb was 12.4 g/dL with a mean change from baseline of 6.27 g/dL (p = 0.005). By Day 57 (after 2 doses), all OMS906-treated patients achieved an increase in Hgb of 4.0 g/dL or more, with a mean change from baseline of 4.75 g/dL (p < 0.001). View the full release here: įigure 1: Mean Hemoglobin Change from Baseline Over Time (Graphic: Business Wire) 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). 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.All OMS906-treated patients remained transfusion-free throughout the observation period.Following 3 doses of OMS906, mean hemoglobin increase from baseline was 6.27 g/dL (p = 0.005).Following 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 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 period
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