ENGLEWOOD, Colo., Dec. 17, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today 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 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 ("SMC") 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 ("WHO") clinical improvement scale and the National Early Warning Score ("NEWS2"), 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.
- Additionally, Ampion-treated patients showed greater improvement compared to patients treated with the SOC, including anti-viral therapies.
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.
About Ampio Pharmaceuticals
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").
Forward Looking Statements
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," 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 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.
SOURCE Ampio Pharmaceuticals, Inc.