{"id":449975,"date":"2021-03-03T16:04:28","date_gmt":"2021-03-03T21:04:28","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=449975"},"modified":"2021-03-03T16:04:28","modified_gmt":"2021-03-03T21:04:28","slug":"ampio-pharmaceuticals-inc-reports-fourth-quarter-2020-financial-results-and-provides-business-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ampio-pharmaceuticals-inc-reports-fourth-quarter-2020-financial-results-and-provides-business-update\/","title":{"rendered":"Ampio Pharmaceuticals, Inc. Reports Fourth Quarter 2020 Financial Results and Provides Business Update"},"content":{"rendered":"
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FDA recommends we conduct a randomized, double-blinded, placebo-controlled Phase II for Intravenous (IV) and Inhaled Ampion to allow consideration of EUA treatment of COVID-19 patients<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n ENGLEWOOD, Colo.<\/span>, March 3, 2021<\/span> \/PRNewswire\/ —\u00a0Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today reported annual financial results for the year ended December 31, 2020<\/span> and provided a corporate overview \/ business update.<\/p>\n

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Mr. Michael Macaluso<\/span>, President and CEO, noted, “The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded, placebo-controlled Phase II trial in each.\u00a0 They also indicated that their recommended trial design for both will allow for an effective and efficient review of data results, determine the safety and statistical significance and effectiveness of Ampion in comparison to Standard of Care, all of which are necessary for the FDA to objectively determine that the known and potential benefits of Ampion outweigh the known and potential risks and, consequently, Ampion may be considered for emergency use authorization (EUA). <\/p>\n

In addition, we have provided a detailed proposal to the FDA in response to their recent guidance regarding the status of our Osteoarthritis of the Knee (OAK) Phase III clinical trial, which is paused as a result of the COVID pandemic.\u00a0 In summary, our response proposes analysis of the existing data in a reduced level of patients who had completed the 12-week study regimen for submission.\u00a0 It is important to note that this response is part of\u00a0 an ongoing active dialog with the FDA and until the FDA renders a final decision, this trial data will continue to remain paused and blinded to ensure clinical trial integrity.<\/p>\n

Ampion is a platform biologic and, as such, is agnostic to whether it is treating a COVID patient or an osteoarthritis auto- immune condition. Simplified, Ampion directly and effectively addresses inflammation. \u00a0Consequently, our ongoing and continued research and clinical trials may be applicable to a significant number of additional disease complications, not just COVID.”<\/p>\n

Mr. Michael Macaluso<\/span>, President and Chief Executive Officer, Dr. David Bar-Or, Director and Founder, Ms. Holli Cherevka<\/span>, Chief Operating Officer and Mr. Daniel Stokely<\/span>, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET<\/span> (see details below).\u00a0 <\/p>\n

The key areas of focus will be as follows:<\/p>\n

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\n COVID-19 Platform \/ Pipeline Overview and Update<\/u>
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