Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion (AP-014) is 55% enrolled.
The Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. Inhaled Ampion specifically targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with respiratory distress due to COVID-19.
"We've received amazing feedback from healthcare providers about the improvement seen in patients receiving inhaled Ampion," said Mike Macaluso, CEO of Ampio Pharmaceuticals. "We continue to remain very optimistic at the early, anecdotal evidence regarding the clinical effectiveness of inhaled Ampion in COVID-19 patients, and eagerly await the full results of this trial."
"Our experience using inhaled Ampion to treat patients with COVID-19 continues to trend positively showing no serious drug-related adverse effects," said Chief of Medical Staff for Penrose-St. Francis Health Services Michael Roshon, MD, PhD. "We look forward to seeing the full results of the study as therapeutics for COVID-19 continue to be in high demand."
More than 22 million people in the United States have been diagnosed with COVID-19, making up nearly a quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are and will continue to be necessary to treat patients suffering from some of the virus' most challenging and damaging effects, including, but not limited to, systemic inflammation in the lungs.
Currently, the study of inhaled Ampion in COVID-19 patients has exhibited no drug-related serious adverse events (SAE). Feedback from the Safety Monitoring Committee (SMC), analyzing any safety concerns related to inhaled Ampion, is expected later this month.
In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. In addition to the U.S. based trial of inhaled Ampion, Ampio Pharmaceuticals has initiated a global study commencing in Israel and the U.S. for patients with moderate to severe COVID-19, assessing the safety and efficacy of intravenous Ampion treatment in both a hospital setting and as a therapy for out-patient care.
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