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FDA Grants Ampio Pharma IND and Approves Phase 1 Trial for Inhaled Ampion in COVID-19 Patients

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Ampio Pharmaceuticals traded 15% higher reaching a new 52-week high after the company reported that the U.S. FDA granted an IND and approved the clinical trial protocol for inhaled Ampion for use in COVID-19 patients with respiratory distress.

Ampio Pharmaceuticals Inc. (AMPE:NYSE.American), which is focused on the development novel therapies to treat common inflammatory conditions with limited existing treatment options, today announced "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 AmpionTM as an inhalation therapy for respiratory distress due to COVID-19 infection."

The firm advised that it will build upon the positive results it recently achieved in its Phase 1 trial of Ampion that was administered intravenously to COVID-19 patients. The company indicated that unlike the recent Phase 1 study, the current Phase 1 trial will be for inhaled Ampion. The study plans to enroll 40 patients in a multi-center, randomized trial to evaluate the safety and efficacy of inhaled Ampion. The company stated that inhaled Ampion will be added to the existing standard of care protocol for hospitalized COVID-19 infected patients experiencing respiratory distress.

Ampio Pharmaceuticals stated that "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 firm stated that the FDA utilized safety and efficacy data supplied by Ampio from comprehensive preclinical laboratory studies to grant this IND for inhaled Ampion. The company noted that toxicology studies demonstrated that Ampion is safe for inhalation and it can effectively reduce signaling proteins responsible for tissue damage and pulmonary complications.

The company asserted that the newly issued IND along with its other active INDs that permit introduction of Ampion both intravenously and via intraarticular injection builds upon the firm's potential as a platform drug capable of treating multiple conditions characterized by inflammation.

The company explained inflammation is a biological response to stimuli that the body interprets as having a potentially harmful effect. The firm pointed out that "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 occurs in numerous severe medical conditions including allergy, asthma, autoimmune disorders, inflammatory bowel disease, transplant rejection and many other diseases.

Ampio Pharmaceuticals is a development stage biopharmaceutical company headquartered in Englewood, Colo. The firm is presently concentrating its efforts on the development of Ampion to treat highly prevalent inflammatory conditions for which there are limited treatment options. The company stated that "its 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)."

Ampio Pharmaceuticals started the day with a market capitalization of around $166.2 million with approximately 176.5 million shares outstanding and a short interest of about 9%. AMPE shares opened nearly 36% higher today at $1.28 (+$0.3386, +35.97%) over Friday's $0.9414 closing price and reached a new 52-week high price this morning of $1.39. The stock has traded today between $1.03 to $1.39 per share and is currently trading at $1.09 (+$0.1486, +15.79%).


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