OMER responds to AF, a one time event? Some )MS 721 trials info updated here.
(But still waiting for news on a SPA for the OMS721 IgA-Nephropathy Ph3 trial.)
investor.omeros.com
While, for the reason stated above, Omeros will not engage in a running dialogue with this writer, the company will respond this one time to correct some of the inaccuracies in yesterday’s statnews.com story. Correct information is and has been publicly available to any individual wishing to obtain accurate background material.
The Superior Court of Washington for King County determined there was a likelihood that Omeroswould prevail on its defamation claim against the “Art Doyle” entity(ies) and granted a motion for preliminary injunction requiring removal of the defamatory reports and prohibiting posting of further defamatory statements.
- As of June 30, 2017, 54 patients had been enrolled in OMS721 Phase 2 clinical trials. Since then, the enrollment number has continued to increase. Presentations of OMS721 clinical data at international scientific meetings span February 2017 through June 2017. These presentations are directed to respective groups of patients and are not intended to reflect total patient counts. In addition, like most biopharmaceutical companies, Omeros does not routinely release all clinical data as they are generated.
- As noted in the company’s press release dated August 4, 2017, more than 150 subjects had been dosed with OMS721, and that number continues to increase.
- On March 16, 2017, Omeros publicly announced that enrollment had opened for its Phase 3 clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome, or aHUS. In connection with this study and consistent with regulations governing clinicaltrials.gov postings, a clinicaltrials.gov filing was made by the company on April 17, 2017. This date, as recorded by the website administrators at the National Institutes of Health, is found on the clinicaltrials.gov summary for this Phase 3 trial.
- The estimated completion date of the aHUS Phase 3 clinical trial for approximately 80 patients is listed as 2020 on clinicaltrials.gov. The posting on clinicaltrials.gov also clearly states that an interim analysis will be conducted following treatment of approximately 40 patients for potential submission for regulatory approval. This is consistent with Omeros’ publicly available statements that, based on discussions with both FDA and the European Medicines Agency, the company received guidance from those regulatory bodies that 40 patients may be sufficient for accelerated approval in the U.S. and for full approval in Europe.
- As noted in the company’s press release in February 2014, subjects in Omeros’ Phase 1 trial were dosed subcutaneously at increasing dose levels, with both subcutaneous and intravenous administration resulting in sustained and high degrees of lectin pathway inhibition. Since then, several cohorts of subjects have been administered repeated subcutaneous doses of OMS721, yielding comprehensive pharmacokinetic/pharmacodynamic (PK/PD) data.
- Intravenous loading followed by subcutaneous maintenance dosing in the aHUS Phase 3 clinical trial is based on those comprehensive PK/PD data. According to the FDA medical review, Alexion similarly used pharmacokinetic modeling to determine the dosing regimen for eculizumab (Soliris®) in the aHUS indication.Omeros, for competitive reasons and consistent with common practice in the industry, has not released any PK/PD data.
- Following submission of a request for breakthrough therapy designation based on Phase 2 clinical data in patients with immunoglobulin A (IgA) nephropathy, Omeros received notification of breakthrough designation for OMS721 in IgA nephropathy in a letter from FDA dated June 8, 2017. As publicly disclosed, the Phase 3 clinical trial in this program is planned to initiate later this year.
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