The FDA granted breakthrough therapy designation to Omeros’ lead human monoclonal antibody (mAb) OMS721 for the treatment of immunoglobulin A (IgA) nephropathy. The antibody targets mannan-binding lectin-associated serine protease-2 (MASP-2). Omeros holds global rights to MASP-2 and therapeutics targeting the lectin pathway effector enzyme.

Breakthrough therapy designation for OMS721 for the IgA nephropathy indication was based on data from Omeros’ Phase II study in patients with kidney diseases including IgA nephropahy, which showed that administering OMS721 therapy for 12 weeks led to a 77% mean reduction in urine albumin-to-creatinine ratios, and a 73% mean reduction in 24-hour urine protein levels. The study data were presented at the recent 54th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress. A Phase III study with OMS721 in patients with IgA nephropathy is now being planned. Seattle-based Omeros has established a compassionate-use program for OMS721 in both the U.S. and Europe.

There is no currently approved therapy for IgA nephropathy, Omeros points out. “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., Omeros chairman and CEO. “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.”

OMS721 is separately undergoing Phase III evaluation for treating atypical hemolytic uremic syndrome (aHUS), and a separate Phase II trial is assessing the antibody against hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA). Phase III programs for the stem cell transplant-associated TMA indication are also being planned. OMS721 has been granted FDA orphan drug status for preventing complement-mediated TMAs, and fast track designation for the aHUS indication.

Omeros’ clinical pipeline includes a PDE10-targeting candidate (OMS824), which is in Phase II development for treating central nervous system disorders including Huntington’s and Schizophrenia, and a PPARγ candidate OMS405, which is also in Phase II development for treating opioid drug and nicotine addiction. The firm has a broad small-molecule and preclinical pipeline, and is exploiting its PharmacoSurgery, G protein-coupled receptor, and antibody platforms.

Omeros’s first marketed drug product, Omidria® (phenylephrine and ketorolac injection) is approved in the U.S. and in Europe for specified indications including the prevention of intraoperative miosis (pupil size reduction), and maintaining mydriasis (pupil dilation) during cataract surgery or lens replacement procedures. The firm reported global Omidria revenues of $12.3 million in the first quarter of 2017, up 69.2% on Q1 2016 figures.

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