As previsouly indicated by Omeros’ CEO, Greg Demopulos, the FDA is keen to accelerate the development of OMS721, a human monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
In spring, Omeros had reported rather impressive data from its Phase II study in patients with IgA nephropathy and other kidney diseases. 12 weeks of Treatment with OMS721 let to improvement in proteinuria with a 77-percent mean reduction in urine albumin-to-creatinine ratios and a 73-percent mean reduction in 24-hour urine protein levels.
If this magnitude of efficacy is confirmed in a larger study, OMS721 would probably have the potential to stop the risk of end-stage renal disease and ultimate kidney failure. There has been growing evidence that the lectin pathway is involved in IgA nephropathy and this study seems to confirm that its inhibition might lead to durable remission.
“We are pleased that FDA has granted breakthrough designation to OMS721 for IgA nephropathy and appreciate the Agency’s recognition of the potential importance of OMS721 in the treatment of this disease,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “OMS721 appears to be helping IgA nephropathy patients with a rapidity and magnitude not previously seen with any other therapy, and we look forward to working closely with the FDA to accelerate its development.”
Omeros will start to enrol patients for the Phase III trial later this year.