Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) has announced that the FDA has granted it an Investigational New Drug (IND), which will allow it to go on with clinical trials of using Ampion™ as a COVID-19 inhalation therapy for respiratory distress.
Ampio to study inhaled Ampion after the success of IV admiration
The phase 1 study of inhaled Ampion will expand the recent successful first phase study of intravenously administered Ampion in COVID-19 patients. The current study will assess the efficacy and safety of inhaled Ampion in combination with standard of care in hospitalized COVID-19 patients experiencing respiratory distress. The subjects will receive ampion through inhalation, which will allow the drug to target directly and attenuate inflammation in the lungs, causing respiratory failure.
Ampio will study the effects of inhaled ampion in this clinical study while at the same time emphasizing early intervention treatment throughout COVID-19 infection clinical progression. The delivery method of ampion will be through a hand-held nebulizer for inhalation for individuals experiencing less severe respiratory illness cases and vial mechanical ventilators for those that have progressed to acute respiratory distress syndrome.
Ampion showed an encouraging safety profile
The FDA used efficacy and safety data from the preclinical laboratory studies that the company provided to issue the IND. According to toxicology studies, Ampion showed encouraging safety profile for inhalation, while more data showed that ampion can reduce signaling proteins responsible for pulmonary complications and tissue damage. The studies have shown that ampion could effectively enhance signaling molecules necessary for repairing tissues and lung healing.
The mechanism of action of Ampion can interrupt pulmonary disease progression and offer necessary relief and recovery for patients experiencing respiratory illness and shortness of breath related to coronavirus. This INDA and the active INDs of Ampio for intravenous and Intraarticular injection of ampion build un the potential of ampion as a drug platform to treat various inflammatory conditions. What has been consistent across clinical trials is that Ampion has been well-tolerated and safe as an anti-inflammatory biologic.