Biopharmaceutical company Ampio Pharmaceuticals Inc (NYSE American:AMPE) reported on Monday the receipt of US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to proceed with clinical trials of the inhaled Ampion for respiratory distress due to COVID-19 infection following the successful Phase I trial that administered Ampion intravenously to COVID-19 patients.

Under a multi-centre, randomized, controlled Phase I trial in a total of 40 patients, the company said it 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.

The company said the approved clinical trial will study the effects of inhaled Ampion throughout the clinical progression of COVID-19 infection. It will be delivered by a hand-held nebulizer for inhalation in patients with less severe cases of respiratory illness and through mechanical ventilators for inhalation in patients with severe respiratory distress syndrome (ARDS).

In conjunction, Ampion's anti-inflammatory biologic is reported to be safe and well-tolerated with no serious drug related adverse events across all clinical trials, concluded the company.