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FDA Grants Ampio Pharma Approval to Begin Phase 1 Trial in COVID-19 Patients

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Ampio Pharmaceuticals' shares traded higher after the company reported that the FDA cleared the firm to proceed with human trials of its Investigative New Drug application for intravenous AmpionTM for treatment in COVID-19 affected patients on supplemental oxygen.

Biopharmaceutical company Ampio Pharmaceuticals Inc. (AMPE:NYSE.American), which is engaged in advancing immunology-based therapies for prevalent inflammatory conditions including developing therapies for patients infected with the SARS-CoV-2 virus (COVID-19), today announced that "The U.S. Food and Drug Administration (FDA) completed its review of the Company's Investigative New Drug (IND) application for intravenous (IV) AmpionTM treatment for COVID-19 affected patients and has cleared the company to proceed with human trials."

The firm advised that it will be starting a Phase 1 clinical study to evaluate IV Ampion as a treatment for COVID-19 patients on supplemental oxygen. The company advised that "the need for supplemental oxygen in COVID-19 patients is indicative of an inflammatory process in the lungs and that as an immunomodulatory anti-inflammatory agent, Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome of patients."

The company further explained that "years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome and the cytokine storm, associated with COVID-19."

Ampio Pharmaceuticals is a development stage biopharmaceutical company headquartered in Englewood, Colo. The firm concentrates it efforts mostly on developing its Ampion product candidate to address the treatment of prevalent inflammatory conditions for which currently there are limited treatment options. The company stated that "its lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act." In addition to treating inflammatory conditions, the company states on its website that it is also developing compounds to address several other areas of significant unmet medical needs in the areas of osteoarthritis and diabetic macular edema.

Ampio Pharmaceuticals has a market capitalization of around $94.0 million with approximately 164.9 million shares outstanding and a short interest of about 7.7%. AMPE shares opened 40% higher today at $0.81 (+$0.57, +42.11%) over yesterday's $0.57 closing price. The stock has traded today between $0.6062 and $0.85 per share and is currently trading at $0.6339 (+$0.0639, +11.21%).

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