Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it has received regulatory approval to expand enrollment of its AP-019 Phase II study to India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19.
“FDA approval to include study sites in India further illustrates the continued need for our therapy,” said Michael Macaluso, President and CEO of Ampio. “Currently, India is reporting an average of more than 3,200 daily deaths from COVID-19 and over 94,000 new cases per day. We expect this expansion to shorten the timeline for overall study enrollment and potentially assist one of the world’s highest density populations of COVID-19 infections.”
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 COVID-19 respiratory distress. Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%.
Due to the ongoing political unrest in Israel and the surrounding region combined with the reduction in COVID cases, the Company has a made a strategic decision to discontinue the AP-019 study efforts in Israel and reallocate and focus these resources to select regions of India and other potential select territories outside the United States, depending on the ongoing magnitude of COVID-19 cases. More information on the Company’s COVID-19 trials can be found at: https://ampiopharma.com/pipeline/ampion-and-inflammatory-lung-diseases-covid-19/