- Ampion-treated patients showed improvement from severe disease/hospitalization to uninfected/ambulatory on the ordinal scale
- Ampion-treated patients showed greater improvement compared to patients treated with the standard of care including anti-viral therapies
- Ampion found to be safe and well-tolerated with no drug related adverse events
ENGLEWOOD, Colo., September 9, 2020, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced positive results in early trial for intravenous (“IV”) AmpionTM treatment for COVID-19 patients. We believe Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome in patients treated with Ampion.
The Phase I trial was led by Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado. The trial was a randomized, controlled study of adults hospitalized, confirmed SARS-COV-2 (“COVID-19”) positive by PCR test and receiving supplemental oxygen. Patients were randomized 1:1 to receive IV Ampion treatment or standard of care, including anti-viral therapies, such as Remdesivir or convalescent plasma, both approved by the FDA under emergency use authorization (“EUA”) as standard of care. The majority of the patients in the control group were prescribed Remdesivir anti-viral treatment while no patients in the IV Ampion group received that anti-viral therapy.
The study met its primary endpoint for the safety and tolerability of IV Ampion treatment, with no remarkable difference in the incidence, frequency, and severity of adverse events between IV Ampion and standard of care.
All patients treated with IV Ampion improved after treatment. At hospital discharge, the IV Ampion treatment group had a stronger clinical improvement than the COVID standard of care control group, as determined by both the World Health Organization (“WHO”) clinical improvement scale1 and the National Early Warning Score (“NEWS2”)2, which is recommended by the National Institute for Health and Care Excellence (“NICE”) in its guidelines for the management of COVID-19 patients in critical care.
Treatment options for COVID-19 are limited and the country continues to observe rising numbers of infection. These Phase I study results provide encouraging results that IV Ampion may be a safe and effective treatment for COVID-19 infected patients admitted to the hospital and needing supplemental oxygen.
Patients will be followed over the upcoming months to complete the safety endpoint assessments for the Phase 1 clinical trial. Safety and efficacy results will be submitted to a peer-reviewed scientific journal and provide the basis for performing a Phase II/III trial with IV Ampion.
1 WHO Clinical Improvement Scale: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf
2 NEWS Critical Intervention Scale: https://www.mdcalc.com/national-early-warning-score-news-2
About Ampio Pharmaceutical
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio’s lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (“BPCIA”).
Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” “may,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (“BLA”), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that IV Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Dan Stokely, CFO
Phone: (720) 437-6500
Ampio Pharmaceuticals, Inc.