Ampio Pharma receives DCGI approval to commence AP-019 Phase II study in India

The study will utilise inhaled Ampion to treat those suffering from respiratory distress due to COVID-19

Ampio Pharmaceuticals, a biopharmaceutical company focussed on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced regulatory approval from the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) in the Phase II AP-019 clinical trial in India. The study will utilise inhaled Ampion to treat those suffering from respiratory distress due to COVID-19.

Following presentation of Ampion to a Subject Expert Committee (SEC) established by the DCGI, the AP-019 treatment protocol was approved with no recommended changes.

Mike Macaluso, President and CEO, Ampio. “We are grateful for the DCGI’s swift attention and believe their decision underscores the critical medical need for Ampion as a potential treatment option.”

As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19 and, as such, may improve the clinical outcome for patients suffering from its complications. Directly administering Ampion to patients by inhalation allows the drug to directly target and attenuate inflammation in the lungs.

The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilising inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial. On April 27, 2021, the company reported the earlier Phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78 per cent over the Standard of Care (SOC) for patients suffering from respiratory distress due to COVID-19. Specifically, mortality in the SOC group was 24 per cent, while in the group treated with SOC and Ampion, mortality was only 5 per cent.

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