ENGLEWOOD, Colo., July 29, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced details on the Company's poster presentation, "Efficient Applied Toxicology during COVID-19: A Preclinical Study that Advanced Clinical Use of Ampion," being given virtually at the American College of Toxicology 42nd Annual Meeting, November 14 to 17, 2021, at the Gaylord National Harbor in Washington, DC.
Ampio's poster is based on the Company's preparations for its recently completed AP-014 Phase I clinical trial utilizing an inhaled form of Ampio's drug, Ampion™, for treatment of respiratory distress in patients as a result of COVID-19. The study showed inhaled Ampion significantly reduced all-cause mortality for patients suffering from COVID-19 induced respiratory distress by 78% over the Standard of Care (SOC) alone. Based on those strong positive results, Ampio has recently undertaken a Phase II trial.
Prior to launching the initial AP-014 trial, Ampio undertook pre-clinical research to establish the safety of its Ampion anti-inflammatory therapy whereby the method of use would be through inhaled delivery. Ampion, a novel biologic drug containing a blood-derived cyclized peptide and other small molecules, with the potential for treating a variety of serious and often life-threatening inflammatory conditions, had previously demonstrated its safety utilizing injection and intravenous (IV) delivery formats in other previously completed trials.
The FDA identified a need to assess the no-observed-adverse-effect level (NOAEL) in animals with Ampion via inhalation as the intended route of administration. Ampio designed a study with FDA feedback to assess the potential local toxicity to the lung and other respiratory tissues at a range of inhalation doses. The company's presentation will highlight the program as an example of efficient development that is responsive to both the COVID-19 pandemic and FDA requirements.
The presentation will be given by Laura Goldberg and Holli Cherevka, both of Ampio Pharmaceuticals based in Englewood, CO, and Philip J. Kuehl of Lovelace Biomedical based in Albuquerque, NM.
For more information on the abstract presentation or American College of Toxicology 42nd Annual Meeting, visit https://www.actox.org/am/am2021/.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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 using 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.