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Blog Coverage: Omeros' Stock Jumped on Completion of IgA nephropathy Cohort and Additional Positive Results

Thursday, 18 May 2017 08:15 AM

Active Wall Street

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LONDON, UK / ACCESSWIRE / May 18, 2017 / Active Wall St. blog coverage looks at the headline from Omeros Corp. (NASDAQ: OMER) as the Company announced on May 17, 2017, the completion of the IgA nephropathy cohort and also reported additional positive results from the first stage of the Company's Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders. Register with us now for your free membership and blog access at:

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One of Omeros' competitors within the Biotechnology space, Halozyme Therapeutics, Inc. (NASDAQ: HALO), reported on May 09, 2017, its financial results and recent highlights for Q1 ended March 31, 2017. AWS will be initiating a research report on Halozyme Therapeutics in the coming days.

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What is OMS721?

OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system's lectin pathway. The additional Phase 2 results in IgA nephropathy patients demonstrated statistically significant improvement in urine protein levels (proteinuria), which is associated with slowing progression of kidney functional loss, and progressively better prognoses.

The first stage in this Phase 2 trial includes four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy.

Patients of the IgA nephropathy cohort were treated open-label with OMS721 for a total of 12 weeks and then followed post-treatment for six weeks. All IgA nephropathy patients had stage 3B chronic kidney disease and three of the four patients had nephrotic range proteinuria. All patients demonstrated marked improvement in urine albumin-to-creatinine ratio (uACR) and in 24-hour urine protein excretion while concurrently tapering corticosteroid treatment. The mean baseline uACR in these patients was 1,457 mg/g and reached 332 mg/g at the end of the follow-up period. Results of 24-hour urine protein excretion were highly consistent with the uACR results, with a reduction from a mean of 3,935 mg/day at baseline to a mean of 1,067 mg/day at the end of the follow-up period. All patients achieved partial remission based on proteinuria and one patient with nephrotic range proteinuria achieved a 95% reduction.

"We are pleased with the continued consistency of the results seen in these patients treated with OMS721," stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, "Despite being an orphan disease, IgA nephropathy is the most common primary glomerular disease worldwide, and we are keenly focused on this indication for OMS721. We are aggressively advancing to our Phase 3 clinical trial and look forward to beginning patient enrollment as soon as possible."

Currently, there are no treatments approved for IgA nephropathy. As per the press release, it is estimated that 1 in 1,400 persons in the US will develop IgA nephropathy in his or her lifetime, and approximately 40% of them may develop end-stage renal disease.

Moving Forward

Apart from preparing for the Phase 3 clinical trial in IgA nephropathy, Omeros is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy. Furthermore, following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is also in progress

The Company also has two Phase 2 trials in progress, one evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis, the second trial has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. The FDA has granted OMS721 both orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS.

Stock Performance

On Wednesday, May 17, 2017, following the announcement, the stock closed the trading session at $16.25, jumping 8.70% from its previous closing price of $14.95. A total volume of 1.97 million shares have exchanged hands, which was higher than the 3-month average volume of 639.47 thousand shares. Omeros' stock price soared 40.33% in the last three months, 20.73% in the past six months, and 52.58% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 63.81%. At Wednesday's closing price, the stock's net capitalization stands at $710.13 million.

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