Ampio enrolling patients for inhalable COVID-19 Phase I trial

14-Jan-2021 - Last updated on 15-Jan-2021 at 15:25 GMT

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The immunotherapy-focused firm reports enrollment stands at 55% for its ongoing study exploring viability of Ampion as an inhalable COVID-19 treatment.

Ampio Pharmaceuticals, a company specializing in immunology-based therapies for inflammatory conditions, has announced that its ongoing Phase I clinical trial in the US, exploring inhalation treatment of COVID-19 with Ampion (AP-014), is now 55% enrolled. The trial is looking at the impact of inhaled Ampion treatments in patients suffering respiratory distress as a result of COVID-19 infection.

Inhaled Ampion specifically targets inflammation in the lung. Researchers are hopeful that the use of the drug stands to improve the clinical outcome for patients with respiratory distress due to COVID-19.

To date, according to Ampio CEO Mike Macaluso, researchers are hopeful about Ampion’s promise to treat patients dealing with the virus.

“We've received amazing feedback from healthcare providers about the improvement seen in patients receiving inhaled Ampion," Macaluso said. “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."

Michael Roshon, chief of medical staff for Penrose-St. Francis Health Services, said, “Our experience using inhaled Ampion to treat patients with COVID-19 continues to trend positively showing no serious drug-related adverse effects. We look forward to seeing the full results of the study as therapeutics for COVID-19 continue to be in high demand.”

As of early 2021, more than 22m Americans have been diagnosed with COVID-19; this figure comprises nearly 25% of the total cases around the world (the US is home to 4% of the world's population). While vaccines are increasingly available, pharmaceutical firms and their research partners remain hard at work in the pursuit of therapies to treat COVID-19 patients, including those suffering from most challenging and damaging effects (such as systemic inflammation in the lungs).

Researchers report that so far, the study of inhaled Ampion in COVID-19 patients has exhibited no drug-related serious adverse events (SAE). The company reportedly anticipates feedback from the Safety Monitoring Committee (SMC), analyzing any safety concerns related to inhaled Ampion, to come through later this month.

Ampion in vitro interrupts the hyper-active immune response, known as cytokine storm, that 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.

Along with the US-based trial of Ampion, Ampio Pharmaceuticals reports it has initiated a global study in Israel and the US for patients with moderate to severe COVID-19. This trial is centered on assessment of the safety and efficacy of intravenous Ampion treatment in both a hospital setting and as a therapy for out-patient care.