OMS721, a human monoclonal antibody selectively targets MASP-2 which expands to mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of the complement system.
The breakthrough therapy designation has been given following the phase 2 trial on patients with IgA nephropathy and other kidney diseases. In the trial, there was a significant improvement in proteinuria, a key marker for disease progression in IgA nephropathy patients and an improvement in it is related with positive clinical outcomes. OMS721 has shown improvement in proteinuria during 12-week treatment.
Omeros recorded a mean reduction of 77% in urine albumin-to-creatinine ratios, and a mean reduction of 73% in 24-hour urine protein levels.
With the breakthrough therapy designation, OMS721 will have an earlier review by the FDA regarding its approval for treating IgA nephropathy.
Omeros chairman and CEO Gregory A. Demopulos said: “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.
“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.”
According to Omeros, OMS721 is the first drug candidate in development to have been given the FDA breakthrough therapy designation for the treatment of IgA nephropathy.
The biopharma is pinning hopes on OMS721 to become the first approved treatment by the FDA for IgA nephropathy.
It is planning to conduct a second phase 3 clinical trial for OMS721 in the current year.
Simultaneously, the MASP-2 inhibitor is also being evaluated in a phase 3 atypical hemolytic uremic syndrome trial and also in a phase 2 trial for hematopoietic stem cell transplant-associated thrombotic microangiopathy.