FDA Grants IND, Approves Trial Protocol of Inhaled Ampion for COVID-19

Ampio Pharmaceuticals announces the receipt of an Investigational New Drug (IND) from the U.S. Food and Drug Administration (FDA), allowing the Company to proceed with clinical trials for the use of Ampion as an inhalation therapy for respiratory distress due to COVID-19 infection.

Expanding on the recently successful Phase I trial that administered Ampion intravenously to COVID-19 patients, the current Phase I trial of inhaled Ampion will be a multi-center, randomized, controlled trial for a total of 40 patients, and will assess the safety and efficacy of inhaled Ampion added to the standard of care (SOC) for COVID-19 infected patients hospitalized for respiratory distress. Ampion will be delivered by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs that can lead to respiratory failure. This approved clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the clinical progression of COVID-19 infection. Ampion will be delivered by a hand-held nebulizer for inhalation by patients with less severe cases of respiratory illness and through mechanical ventilators to those patients who have progressed to severe respiratory distress syndrome (ARDS).

The FDA relied on safety and efficacy data from comprehensive preclinical laboratory studies provided by Ampio to Grant this IND. Toxicology studies demonstrated that Ampion is safe for inhalation, and extensive laboratory data indicates that Ampion can effectively reduce signaling proteins responsible for tissue damage and pulmonary complications. These studies also revealed that Ampion can effectively increase signaling molecules required for tissue repair and healing in the lungs. Ampion's mechanism of action may interrupt the pulmonary disease process and provide much needed relief and recovery for patients suffering from shortness of breath and respiratory illness related to COVID-19 infection.

The current IND along with Ampio's active INDs for the introduction of Ampion intravenously and by intraarticular injection builds upon Ampion's potential as a platform drug, treating multiple conditions characterized by inflammation.  A recurring theme across all clinical trials with Ampion is that this anti-inflammatory biologic has been safe and well-tolerated with no serious drug related adverse events.

Inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect. Inflammatory disorders that result in a dysregulated immune response by attacking the body's own cells or tissues may result in chronic pain, tissue damage and loss of function. Inflammation plays a major role in many disease processes including allergy, asthma, autoimmune disorders such as hepatitis, inflammatory bowel disease, transplant rejection and more.