Ampio Pharmaceuticals Announces Important New Research Manuscript on Anti-Inflammatory Mode of Action

Research shows Ampion may be used to treat conditions that are supported for dexamethasone but with fewer or less harmful side effects

ENGLEWOOD, CO, August 13, 2021Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, today announced a preprint version of a manuscript, “LMWF5A Demonstrates an Anti-Inflammatory Mode of Action and Similar Drug Targets to Dexamethasone in Activated PBMC,” has been posted on In Review, a preprint platform hosted on Research Square.

The paper highlights important preclinical research done on the mode of action of Ampion™, Ampio’s novel anti-inflammatory biologic therapy, showing that Ampion may be used to treat conditions that are supported for dexamethasone but with fewer or less harmful side effects.

“It is imperative that new research on possible treatments be shared as quickly as possible,” said David Bar-Or, M.D., Director and Founder of Ampio Pharmaceuticals and a co-author of the paper. “This research demonstrates an opportunity to provide anti-inflammatory benefit with limited side effects with Ampion treatment. Making this paper available in preprint format on In Review makes research communication faster, fairer, and potentially more useful in the fight against COVID-19.”

Ampio Pharmaceuticals is currently conducting two Phase II clinical trials for use of Ampion in treating COVID-19, in an inhaled format for COVID-19 related respiratory distress and intravenously (IV) for systemic complications. Additional trials are underway for “long-haul” COVID-19 and osteoarthritis of the knee (OAK).

The preprint paper stems from an unbiased investigation of Ampion’s effects on activated immune cells in various conditions. Differential gene expression analysis determined transcriptional changes due to Ampion treatment, and Ingenuity Pathway Analysis software identified compounds with comparable or contrasting activities to Ampion. Analysis revealed broad anti-inflammatory and pro-resolving activities for Ampion, with predicted inhibition of key pro-inflammatory mediators and functions as well as activation of some anti-inflammatory mediators.

Upstream regulator analysis identified dexamethasone as the most significantly similar drug. Further comparison of Ampion and dexamethasone revealed similar, but not identical, targets and directional regulation. This study supports the current knowledge on the mode of action of Ampion and provides new hypotheses for future investigations. Due to its analogous biological effects compared to dexamethasone and its known safety profile, Ampion may be used to treat conditions that are supported for dexamethasone with fewer or less harmful side effects.

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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 “could,” “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s ability to access equity financing and fund research and development programs and operations through the fourth quarter of 2022, expectations with respect to Ampion, including its ability to treat prevalent inflammatory conditions for which there are limited treatment options (including COVID-19) and its ability to offer the benefits of steroids without the side effects, the significance of reported results in early clinical trials, the timing of patient enrollment for the Phase I Long-COVID trial and the Phase II COVID-19 trials, the timing and outcome of the Company’s application for Emergency Use Authorization of Ampion in COVID-19 patients with inhalation and intravenous routes of drug delivery, the term of Ampion’s patent protection and the timing and likelihood of Ampion’s approval as a novel biologic under the BPCIA, including the availability of 12-year FDA market exclusivity in connection with such approval. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Ampio and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. 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, in 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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