Ampio Pharma wins DCGI nod to begin AP-019 study to treat Covid-linked respiratory distress
Englewood: Ampio Pharmaceuticals, a biopharmaceutical company has recently 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 utilize 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.
"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," said Mike Macaluso, President & CEO of 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."
India has experienced over 33 million infections and over 440 thousand reported coronavirus-related deaths since the pandemic began, making it the country with the largest number of COVID-19 infections and deaths in the Middle East and Asia. While new infections are at 10% of their peak in early May, COVID-19 remains a continuing health threat in India.
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, utilizing 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% over the Standard of Care (SOC) for patients suffering from respiratory distress due to COVID-19. Specifically, mortality in the SOC group was 24%, while in the group treated with SOC and Ampion, mortality was only 5%.
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