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Corporate News Blog - FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of IgA Nephropathy

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LONDON, UK / ACCESSWIRE / August 8, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Omeros Corp. (NASDAQ: OMER), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=OMER. The Company announced on August 04, 2017, that its lead human monoclonal antibody OMS721 has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy. For immediate access to our complimentary reports, including today's coverage, register for free now at:


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Immunoglobulin A nephropathy

OMS721 is Omeros' lead human monoclonal antibody which targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. IgA nephropathy is the most common primary glomerulopathy globally with around 120,000 to 180,000 cases in the US alone. It accounts for 10% of all dialysis patients. In fact, up to 40% of individuals with this disease develop end-stage renal disease, a life-threatening condition, within 20 years after diagnosis.

FDA grants OMS721 breakthrough therapy designation

The Phase-2 clinical trial results with OMS721 in IgA nephropathy patients demonstrate unparalleled decline in urine protein levels during and following treatment with OMS721. Raised urinary protein is highly correlated with poor outcomes in patients with IgA nephropathy. As a consequence to this data review, FDA granted OMS721 breakthrough therapy designation for the treatment of IgA nephropathy in June 2017. The Company aims to commence enrollment of patients in its Phase-3 registration trial in IgA nephropathy towards the end of 2017.

FDA grants OMS721 orphan designation

FDA has granted OMS721 orphan designation with the intention of promoting the development of a drug that is expected to have a noteworthy therapeutic advantage over existing treatments for a condition affecting around 200,000 US patients annually. The orphan designation qualifies the Company for benefits that apply across all stages of drug development, including seven years of market exclusivity following marketing approval, tax credits on US clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.

Another Phase-3 program for OMS721 in IgA nephropathy

Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, announced that the Company was working with FDA on initiating another Phase-3 program for OMS721 in IgA nephropathy, which has been granted both breakthrough and orphan designations. This is the second Phase-3 program for OMS721 while the ongoing aHUS program has already received fast track status from FDA. Moreover, he mentioned that a third Phase-3 program for OMS721 could also be added this year in stem cell transplant-associated thrombotic microangiopathy and that, along with aHUS, has been granted orphan designation. Gregory A. Demopulos also expressed that Omeros is focused on bringing OMS721 to market as quickly as possible. He was excited about the benefits that OMS721 is expected to provide for patients across a wide range of serious and life-threatening disorders. As of now, over 150 subjects worldwide have received OMS721 and no safety concerns have been noted yet.

About Omeros' MASP Programs

Omeros owns the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays an important role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. And the MASP-2 is the effector enzyme of the lectin pathway, which is one of the principal complement activation pathways.

Essentially, the inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Its abnormal function is related to a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. However, adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. OMS721 is Omeros' lead human MASP-2 antibody.

Omeros sees MASP-3 responsible for the conversion of pro-factor D to factor D and as a critical activator of the human complement system's alternative pathway. The alternative pathway is linked to a range of immune-related disorders. In addition to its lectin pathway inhibitors, the Company is advancing its development of antibodies and small-molecule inhibitors against MASP-3 to block activation of the alternative pathway. Omeros is also preparing to initiate manufacturing scale-up of its MASP-3 antibodies in advance of clinical trials.

Last Close Stock Review

At the closing bell, on Monday, August 07, 2017, Omeros' stock climbed 1.05%, ending the trading session at $22.15. A total volume of 416.85 thousand shares have exchanged hands. The Company's stock price skyrocketed 43.55% in the last three months, 123.74% in the past six months, and 77.20% in the previous twelve months. Moreover, the stock soared 123.29% since the start of the year. The stock currently has a market cap of $970.81 million.

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