Friday December 18, 2020 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial for intravenous ("IV") Ampion treatment in COVID-19 patients.
The Phase I study was a randomized, controlled study of adults hospitalized with severe COVID-19, the company said. The primary endpoint for the study was evaluated after a 5-day treatment period, and safety was followed for an additional 3 months.
Half of the patients received IV Ampion plus the standard of care ("SOC") for COVID-19 while the other half received SOC alone.
The following highlights were observed:
- Based on data review, the Safety Monitoring Committee found the IV treatment of Ampion to be safe and well-tolerated for 90-days following treatment.
- The study met its primary safety endpoint after 5 days of IV Ampion treatment and again after 3 months, with no remarkable safety differences between the Ampion treatment and SOC control groups.
- The study showed promising efficacy with the IV Ampion treatment group seeing stronger clinical improvement than the SOC group as measured by the World Health Organization clinical improvement scale and the National Early Warning Score, which is recommended by the National Institute for Health and Care Excellence in its guidelines for the management of COVID-19 patients in critical care.
- Additionally, Ampion-treated patients showed greater improvement compared to patients treated with the SOC, including anti-viral therapies.
Ampio said the beneficial clinical applications for IV Ampion treatment in COVID-19 patients will be further explored using two treatment groups in a larger Phase II study while building on the safety profile from the Phase I study.
The following highlights are presented:
- Clinical sites in Israel will be used concurrently with sites in the United States, as Israel has been recognized by the FDA as capable for sharing knowledge and inspection information to support the safety and efficacy of drugs in the United States.
- In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, associated with COVID-19 infection. IV Ampion targets systemic inflammation in the body observed with COVID-19 patients, which is being investigated to improve the clinical course of the diseases and outcomes in patients treated with Ampion.
- The IV Ampion clinical program complements ongoing clinical studies evaluating inhaled Ampion, which targets localized inflammation in the lungs.