Shares of Ampio Pharmaceuticals Inc. (AMPE) were last seen at $2.08 in premarket trading, up 15.56%. Ampio stock closed last session at $1.80, gaining 1.12%, or $0.02. AMPE stock traded between $1.77 and $1.83 during the past session.

Volume of the traded shares was 1.24 million, a lower number than AMPE’s 50-day volume of 1.43 million and below its Year to Date volume of 2.73 million. AMPE stock has surged after receiving approval to expand enrollment in a study.

Which study received approval?

Biopharmaceutical company Ampio focuses on developing immunological-based treatments for common inflammatory conditions for which limited treatment options exist. AMPE’s lead drug, Ampion, is protected by a broad patent portfolio that lasts until 2035. AMPE’s that drug will also qualify for 12-year FDA market exclusivity once it is approved as a novel biologic under the biologic price competition and innovation act (BPCIA).

Today, Ampio announced that regulatory approval had been received for the expansion of enrollment of its AP-019 Phase II study to India.

• Patients suffering from respiratory distress due to COVID-19 will be treated with inhaled Ampion in the study.
• The FDA approval of AMPE’s therapy for study in India highlights the need for the treatment to continue.
• There are currently more than 3,200 deaths per day due to COVID-19 in India, and more than 94,000 new cases are reported daily.
• The expansion of the study should shorten the enrollment period and benefit a population afflicted with COVID-19 among the highest densities anywhere in the world.
• Using the results from its AP-014 Phase I trial, Ampion was used in the AP-019 double-blind, placebo-controlled Phase II study.
• AMPE announced on April 27, 2021, that the earlier Phase I study had met its primary endpoints of safety and tolerability.
• Additionally, the top-line results in that AMPE study showed that Ampion reduced COVID-19 respiratory distress all-cause mortality by 78% over Standard of Care (SOC).
• In those treated with SOC, mortality was 24%, compared to only 5% in those treated with Ampion.

Why AMPE has reallocated?

Ampio (AMPE) has made the strategic decision to discontinue the AP-019 study efforts in Israel due to the current political unrest in Israel and the surrounding region. As a result of this decision, the AMPE reallocated and refocused these resources towards select areas of India and other potential locations outside the U.S., based on the magnitude of cases of COVID-19.