Omeros Corporation announced additional follow-up data from patients with immunoglobulin A (IgA) nephropathy treated with OMS721 in the Phase 2 clinical trial of glomerulonephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
As presented in June 2017 at the 54th Congress of the European Renal Association-European Dialysis and Transplant Association, patients with IgA nephropathy demonstrated clinically and statistically significant improvement in proteinuria during the course of the clinical trial. After these patients completed the trial, the clinical investigator continued to follow them per standard of care. Follow-up data up to approximately one year after completion of treatment are available.
As previously reported, all four IgA nephropathy patients in the clinical trial demonstrated a substantial reduction in proteinuria measured by both 24-hour urine protein excretion levels and urinary albumin/creatinine ratios (uACRs). In post-trial follow-up, urine protein/creatinine ratios (uPCR) were measured by the investigator according to his practice standard. For purposes of post-hoc comparisons of proteinuria during and after the clinical trial, each post-trial uPCR value was converted to uACR (Zhao, Clin J Am Soc Nephrol 2016;11:947-55).
In follow-up, three of the four patients have maintained reductions in proteinuria. In these three patients uACRs remained reduced at 14 percent, 23 percent, and 24 percent of the patients’ baseline values prior to OMS721 treatment. In addition, a suggestion of improvement in estimated glomerular filtration rate (eGFR), a measure of renal function, was observed in 3 of the 4 patients after the trial. The patient with the most severe reduction in kidney function demonstrated eGFR improvement from 30 mL/min/1.73 m2 to 47 mL/min/1.73 m2, an improvement of 57 percent. OMS721 was well-tolerated in the clinical trial with fatigue and anemia the most commonly reported adverse events.
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