Ampio Announces Early Positive Data in Phase 1 Trial of Inhaled Ampion in COVID-19 Respiratory Distress

- Subjects who received Ampion treatment required less oxygen than standard of care alone.

- Subjects who received Ampion treatment were stable or had improvement on the Ordinal Scale for Clinical Improvement (Ordinal Scale) compared to the standard of care patients.

- Subjects who received Ampion treatment were stable or had improvement on the National Early Warning Score 2 scoring system (NEWS2) compared to the of standard of care patients.

- Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care.

- There have been no drug-related serious adverse events.

- Ampio has inventory on hand. In event the safety and efficacy study is successful, and the product receives regulatory approval, Ampio is in a position to begin immediate manufacturing.

An RN working at a clinical study site said, "The staff is seeing a big difference in the Ampion-treated patients. We believe Ampion kept one patient off a ventilator - and another discharged this past weekend, no one expected him to live. So now we have both respiratory therapy and nursing stating how they are seeing a big difference in your drug."

News provided by

Ampio Pharmaceuticals, Inc.

Feb 01, 2021, 09:15 ET

ENGLEWOOD, Colo., Feb. 1, 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 early positive data from its ongoing U.S. Phase I controlled, observer-blinded clinical trial of inhaled Ampion versus standard of care for patients with COVID-19 respiratory distress (AP-014).

An independent statistical analysis revealed patients administered Ampion needed less oxygen and showed greater clinical improvement than those receiving the standard of care for COVID-19 respiratory complications. Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care, and there have been no drug-related serious adverse events.

On this positive data, Ampio plans to increase the number of patients in the trial from 40 to 140 and has added additional hospitals as study sites. The new hospitals will accelerate the pace of patient enrollment, and the additional data gained from the added patients will help refine and accelerate future clinical trials, as warranted.

More than 25 million people in the United States have been diagnosed with COVID-19, nearly a 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.

In the trial, Ampion is administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs. This trial will now enroll 140 patients, randomized 1 to 1, inhaled Ampion versus standard of care, with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point, with various measurements indicative of efficacy as secondary endpoints. Inhalation is a new method for the administration of Ampion, cleared for clinical use by the Federal Drug Administration (FDA). The Safety Monitoring Committee (SMC), analyzing data from the trial, recently determined there were no safety concerns related to inhaled Ampion in COVID-19 patients.

Preliminary analysis of data from the trial showed Ampion to be an improvement over the standard of care. In fact, patients receiving Ampion treatment required less oxygen, and were stable or exhibited improvement on the Ordinal Scale and NEWS2 scale, compared to the standard of care patients, respectively. The Ordinal Scale was developed by the World Health Organization (WHO) as a way to determine clinical improvement of COVID-19 patients. The NEWS2 was similarly recommended by the National Institute for Health and Care Excellence (NICE) in its guidelines for the management of COVID-19 patients in critical care.

The analysis also showed Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care patients.

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.

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SOURCE Ampio Pharmaceuticals, Inc.