The company’s findings will be showcased to over 400 clinicians, respiratory health and critical care professionals, aerosol scientists, engineers, product development and regulatory experts
ENGLEWOOD, CO, May 21, 2021 – Ampio Pharmaceuticals (NYSE American: AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced details on the company’s poster presentation, “Regulatory Decisions during COVID-19: Efficient Nonclinical Inhalation Toxicology for a Clinical Program,” being given at the 23rd International Congress of the International Society for Aerosols in Medicine (ISAM), in Boise, Idaho, May 22 to 26, 2021.
The 23rd ISAM Congress is being held as a hybrid event. All posters will be posted both on the website – along with an oral presentation – and printed for display at the Boise Conference Center. The poster itself can also be found here on the “Publications” page on the Ampio Pharmaceuticals website.
In addition to its poster presentation, number 070, the company has been invited to present at a workshop of the Regulatory/Standardization issues networking group, which recently published an appeal on the urgent need to accelerate the development of inhaled therapies for COVID-19. The workshop, entitled “Regulatory Guidance and Standards Required for the detection, prevention of transmission, and development and approval of inhaled vaccines and treatments for SARS -CoV-2 infections,” is scheduled on Saturday, May 22, 2021, from 1:00 pm to 5:00 pm, and the Ampio poster presentation takes place from 4:00 pm to 5:00 pm.
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™, in treating respiratory distress in patients as a result of COVID-19. The study showed inhaled Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) alone.
Prior to launching the trial, Ampio undertook pre-clinical research to establish the safety of its Ampion anti-inflammatory therapy in an inhaled format. 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.
For more details on the ISAM Congress and the timing of Ampio’s presentation, visit: www.isam.org.
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 2035 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.