Ampio Pharmaceuticals Inc. (NASDAQ: AMPE) stock gained by 4.71% at last close whereas the AMPE stock price declines by 2.65% in the pre-market trading session. AMPE has acquired regulatory clearance to expand the AP-019 Phase II study’s enrolment to India. The research will use inhaled Ampion to treat those who have COVID-19-related respiratory distress.
What is happening?
AMPE has acquired regulatory clearance to expand the AP-019 Phase II study’s enrolment to India. The research will use inhaled Ampion to treat those who have COVID-19-related respiratory distress.
Michael Macaluso, President and CEO of Ampio said,
The FDA’s permission to additional trial sites in India demonstrates the therapy’s ongoing need. COVID-19 has claimed the lives of over 3,200 people per day in India, with over 94,000 new cases being reported every day. AMPE anticipate that this extension will decrease the overall trial enrollment timeframe and may help one of the world’s most densely populated COVID-19 infection groups.
Following the positive top-line findings from its AP-014 Phase I study, AMPE began the AP-019, a double-blind, placebo-controlled Phase II experiment using inhaled Ampion. On April 27, 2021, AMPE announced that the previous Phase I trial not only fulfilled its main goal of efficacy and tolerability, but also that top-line findings indicated that Ampion decreased all-cause mortality in COVID-19 respiratory distress by 78 percent when compared to the Standard of Care (SOC). In particular, mortality in the SOC group was 24 percent, while mortality in the Ampion group was just 5%.
AMPE has made the strategic choice to end the AP-019 research activities in Israel due to continuous political turmoil in Israel and the nearby areas, as well as a decrease of COVID patients. Also, based on the continued volume of COVID-19 instances, reallocate and target these resources to chosen parts of India and other possible chosen areas outside the United States.