Business
Omeros Corporation Reports Interim Data with Alternative Pathway Inhibitor OMS906 as Monotherapy in Patients with Paroxysmal Nocturnal Hemoglobinuria
At lowest planned subcutaneous dose, Omeros’ MASP-3 inhibitor OMS906 showed clinically and statistically significant improvements in hemoglobin and LDH,
About this update from Omeros Corporation
[{"type":"text","content":"\nAt 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\n\n\n\nFollowing 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 \n\n\nFollowing 3 doses of OMS906, mean hemoglobin increase from baseline was 6.27 g/dL (p = 0.005)\n\n\n\n\nAll OMS906-treated patients remained transfusion-free throughout the observation period\n\n\n\n\nOMS906 was well tolerated with no safety signals of concern\n\n\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros 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. Statistically significant and clinically meaningful improvements were observed in all measured markers of hemolysis, including hemoglobin (Hgb) and lactate dehydrogenase (LDH). To date, all patients have received only the lowest subcutaneous dose of OMS906 in this multidose trial.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230425005573/en/Figure 1: Mean Hemoglobin Change from Baseline Over Time (Graphic: Business Wire)\nThe baseline mean Hgb was 6.78 g/dL. 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 \nThe mean baseline LDH was 1931, nearly 8 times the upper limit of normal. 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.\n\n\nOMS906 has been safe and well tolerated in this trial, consistent with Phase 1 safety observations in healthy subjects.\n\n\nThis single-arm, open-label clinical trial is evaluating the effect of once-monthly subcutaneous administration of OMS906 in patients with PNH. A total of 9 patients have been enrolled to date and all have been complement-inhibitor-treatment naïve. Co-existi...