Omeros (OMER) announced that the FDA granted breakthrough therapy designation to pipeline candidate OMS721. The candidate will be used to treat Immunoglobulin A (IgA) nephropathy.
OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2).
The designation was granted based on data from phase II trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases. The data revealed unprecedented improvement in proteinuria following only 12 weeks of OMS721 treatment, with a 77% mean reduction in urine albumin-to-creatinine ratios (p = 0.026) and a 73% mean reduction in 24-hour urine protein levels (p = 0.013).
Following the news, shares of the company went up 2.5%. Shares of Omeros has outperformed the Zacks classified Medical-Products industry in the last one year with the stock gaining 73.3% during this period, compared with the industry’s gain of 12.4%.
The breakthrough therapy designation from the FDA enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease. The designation includes benefits from the eligibility for priority review of the application and rolling submission of portions of the application. The FDA personnel, including senior management, provide guidance to the company to determine the most efficient route to approval.
Approximately 120,000 to 180,000 patients in the U.S. suffer from IgA nephropathy. Since there is no approved treatment for IgA nephropathy, there is a significant unmet need for the same. Approximately 40% of IgA nephropathy patients develop end-stage renal disease.
The successful development and subsequent approval of the candidate will significantly boost the company’s growth prospects.
Meanwhile, OMS721 is also being evaluated in a phase III clinical program for atypical hemolytic uremic syndrome (aHUS) and in a phase II clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
We note that Alexion Pharmaceuticals, Inc.’s ALXN Soliris is also approved for aHUS.
The company plans to initiate additional phase III programs on OMS721 in IgA nephropathy and in stem cell transplant-associated TMA.
Omeros currently has one approved drug, Omidria in its portfolio. The drug was launched in the U.S. in the second quarter of 2015 for use during cataract surgery or intraocular lens, or IOL, replacement.
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