Ampio Pharmaceuticals announced early positive data from its ongoing U.S. Phase I controlled, observer-blinded clinical trial of inhaled Ampion versus standard of care for patients with COVID-19 respiratory distress (AP-014).

An independent statistical analysis revealed patients administered Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care for COVID-19 respiratory complications. Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care, and there have been no drug-related serious adverse events.

On this positive data, Ampio plans to increase the number of patients in the trial from 40 to 140 and has added additional hospitals as study sites. The new hospitals will accelerate the pace of patient enrollment, and the additional data gained from the added patients will help refine and accelerate future clinical trials, as warranted.

More than 25 million people in the United States have been diagnosed with COVID-19, 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.

In the trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs. This trial will now enroll 140 patients, randomized 1 to 1, inhaled Ampion versus standard of care, with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point, with various measurements indicative of efficacy as secondary endpoints. Inhalation is a new method for the administration of Ampion, cleared for clinical use by the Federal Drug Administration (FDA). The Safety Monitoring Committee (SMC), analyzing data from the trial, recently determined there were no safety concerns related to inhaled Ampion in COVID-19 patients.

Preliminary analysis of data from the trial showed Ampion to be an improvement over the standard of care. In fact, patients receiving Ampion treatment required less oxygen, and were stable or exhibited improvement on the Ordinal Scale and NEWS2 scale, compared to the standard of care patients, respectively. The Ordinal Scale was developed by the World Health Organization (WHO) as a way to determine clinical improvement of COVID-19 patients. The NEWS2 was similarly recommended by the National Institute for Health and Care Excellence (NICE) in its guidelines for the management of COVID-19 patients in critical care.

The analysis also showed Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care patients.