Ampio Pharmaceuticals has obtained regulatory approval from the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) to commence the Phase II AP-019 clinical trial of inhaled Ampion in the country.
A lead drug of Ampio, Ampion is an immunomodulatory agent possessing anti-inflammatory effects.
It disrupts the hyperactive immune response linked to Covid-19 and can potentially boost the clinical outcome in patients suffering from its complications.
The inhaled administration of Ampion aids the drug to directly target and reduce inflammation in the lungs, Ampio noted.
It will be used in the double-blind, placebo-controlled Phase II trial to treat individuals with Covid-19-associated respiratory distress.
The move comes after the Subject Expert Committee (SEC) established by the DCGI approved the AP-019 treatment protocol without recommending changes, Ampion noted.
Ampio president and CEO Mike Macaluso said: “More than a year and a half into the pandemic, healthcare practitioners still lack effective and easy-to-use therapies to treat the severe and often fatal respiratory distress experienced by many Covid-19 patients.
“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.”
The commencement of the Phase II trial of inhaled Ampion follows robust strong top-line data obtained from its Phase I AP-014 trial.
In April 2021, the company reported that the Phase I trial failed to meet its primary goal of safety and tolerability.
However, according to the top-line results, the drug was demonstrated to reduce all-cause mortality in Covid-19 respiratory distress by 78% as against the standard of care (SOC) for subjects with Covid-19-linked respiratory distress.
Furthermore, only 5% mortality was observed in subjects receiving SOC plus Ampion versus 24% in the SOC arm.