Additional study sites will accelerate patient enrollment.
Preliminary data shows Ampion improves all-cause mortality.
ENGLEWOOD, Colo., February 23, 2021–Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the addition of two new study sites to further the expansion of its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion (“AP-014”). Principal Investigator Luciano Lemos-Filho, M.D., in Pulmonary and Critical Care and Medical Center Intensive Care Unit Director at Swedish Hospital in Denver, CO, and Principal Investigator David King, M.D., Medical Director at Bozeman Health Clinical Research in Bozeman, MT, bring additional experience to the study and will accelerate the enrollment of patients in the trial.
“Patients suffering from life-threatening lung inflammation due to COVID-19 have a desperate need for treatments,” said Dr. David King of Bozeman Health Clinical Research. “Ampion’s anti-inflammatory effects and its method of action suggest it may offer relief to our patients. We are pleased to be able to work with Ampio Pharmaceuticals in this early-stage trial of Ampion in treating COVID-19 related respiratory distress.”
“Expanding the trial to include these doctors and their clinical sites will enhance our speed and ability to enroll patients and gather the data needed to prove the safety and potential efficacy of Ampion in treating COVID-19,” commented Mike Macaluso, CEO of Ampio Pharmaceuticals. “The trial involves only five days of treatment with Ampion delivered through inhalation, which our research suggests should be sufficient to show clinical effect over the Standard of Care for lung inflammation in COVID-19. Preliminary data from the study shows that Ampion has improved all-cause mortality.”
Nearly 28 million people in the United States have been diagnosed with COVID-19, a full quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are, and will continue to be, necessary to treat patients suffering from some of the virus’ most challenging and damaging effects, such as systemic inflammation in the lungs.
In this trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs. In addition, the trial will enroll 140 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (“SOC”), which can vary depending on patients’ needs but includes any and all of the best procedures and drugs approved by the US Food and Drug Administration (“FDA”) or under Emergency Use Authorization through the FDA for use on patients with COVID-19. Depending on disease severity, the SOC for COVID-19 may include supportive care for complications, including supplemental oxygen and advanced organ support, and therapies such as remdesivir or dexamethasone. Safety is the primary end point of the AP-014 study, with various measurements indicative of efficacy as secondary endpoints. Inhalation is a new method for the administration of Ampion which has been cleared for clinical use by the FDA. Recent analysis of preliminary data showed that patients with COVID-19 respiratory complications and administered inhaled Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care. Finally, inhaled Ampion also improved all-cause mortality.
Ampio Pharmaceuticals continues to evaluate additional clinical sites and expects to expand sites in the near term. Ampion is now used in three active investigational new drug (“IND”) programs – inhalation, IV, and interarticular.
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 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.