ENGLEWOOD, Colo., January 4, 2021, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced an update on the launch of a new global clinical trial for intravenous (“IV”) treatment of COVID-19 with Ampion and provided updates on its ongoing U.S. trial for inhalation treatment of COVID-19.
In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. The latest updates on these trials include:
- Initiation of a global clinical trial for IV treatment of COVID-19 patients, including in out-patient settings
A global study has been initiated in Israel and the U.S. with the focus on patient safety and efficacy, as measured by improvement in the clinical course of the disease and related outcomes for patients with moderate to severe COVID-19. Ampion IV treatment targets systemic inflammation in the body of patients with moderate to severe COVID-19 symptoms. In addition, this study will assess the effect of Ampion IV treatment in both a hospital setting and as a therapy for out-patient care.
- U.S. based clinical trial underway for inhalation treatment of COVID-19 patients expands to new hospitals
A Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. The trial is currently ongoing with no drug-related serious adverse events (“SAEs”) reported to date. The rate of enrollment is expected to increase once requisite front-line workers receive the recently released COVID-19 vaccines. Additional hospitals are also being added to the inhalation study with the goal to conclude enrollment in January. Inhaled Ampion targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with COVID-19. Of note, there have been no drug-related SAEs to date in the inhaled clinical trial.
“While the vaccine will hopefully help many people avoid the more serious complications of COVID-19, the rollout of vaccines will take time and is unlikely to ever reach 100% of the public,” said Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals. “We will no doubt continue to need treatments to provide the essential relief and improve outcomes for patients. We are especially excited to begin the testing of Ampion for COVID-19 in an outpatient setting.”
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.