FDA Grants IND and Approves Clinical Trial Protocol of Inhaled Ampion for COVID-19 Patients with Respiratory Distress

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Sep 21, 2020, 09:15 ET

ENGLEWOOD, Colo., Sept. 21, 2020 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company") announces the receipt of an Investigational New Drug ("IND") from the U.S. Food and Drug Administration ("FDA"), allowing the Company to proceed with clinical trials for the use of Ampion^TM as an inhalation therapy for respiratory distress due to COVID-19 infection.

Expanding on the recently successful Phase I trial that administered Ampion intravenously to COVID-19 patients (https://ampiopharma.com/news/ampio-reports-positive-results-in-early-trial-for-iv-ampion-treatment-in-covid-19-patients/), the current Phase I trial of inhaled Ampion will be a multi-center, randomized, controlled trial for a total of 40 patients, and will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress. Ampion will be delivered by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs that can lead to respiratory failure. This approved clinical trial will study the effects of inhaled Ampion while emphasizing early intervention treatment throughout the clinical progression of COVID-19 infection. Ampion will be delivered by a hand-held nebulizer for inhalation by patients with less severe cases of respiratory illness and through mechanical ventilators to those patients who have progressed to severe respiratory distress syndrome ("ARDS").

The FDA relied on safety and efficacy data from comprehensive preclinical laboratory studies provided by Ampio to Grant this IND. Toxicology studies demonstrated that Ampion is safe for inhalation, and extensive laboratory data indicates that Ampion can effectively reduce signaling proteins responsible for tissue damage and pulmonary complications. These studies also revealed that Ampion can effectively increase signaling molecules required for tissue repair and healing in the lungs. Ampion's mechanism of action may interrupt the pulmonary disease process and provide much needed relief and recovery for patients suffering from shortness of breath and respiratory illness related to COVID-19 infection.

The current IND along with Ampio's active INDs for the introduction of Ampion intravenously and by intraarticular injection builds upon Ampion's potential as a platform drug, treating multiple conditions characterized by inflammation. A recurring theme across all clinical trials with Ampion is that this anti-inflammatory biologic has been safe and well-tolerated with no serious drug related adverse events.

About Inflammatory Diseases
Inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect. Inflammatory disorders that result in a dysregulated immune response by attacking the body's own cells or tissues may result in chronic pain, tissue damage and loss of function. Inflammation plays a major role in many disease processes including allergy, asthma, autoimmune disorders such as hepatitis, inflammatory bowel disease, transplant rejection and more.

About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is 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," "may," "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, the timing and outcome of clinical trials, and 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.

Company Contact
Daniel G. Stokely, CFO
Phone: (720) 437-6500
[email protected]

SOURCE Ampio Pharmaceuticals, Inc.