Ampio Pharmaceuticals’ Study Shows Ampion Inhibits a Key Inflammatory Pathway in COVID-19 and Lupus Nephritis

Laboratory results suggest Ampion’s suitability for addressing kidney diseases and provides further evidence it is a platform biologic for treatment of inflammatory and autoimmune diseases.

ENGLEWOOD, CO, April 6, 2021Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the results of a pre-clinical study demonstrating that Ampion inhibits an important pro-inflammatory pathway in the types of immune cells implicated in COVID-19 and Lupus Nephritis.

The aim of the investigation was to evaluate the ability of Ampion to suppress TRL7 signaling and, thereby, reduce the pro-inflammatory chemokine, CXCL10. Toll-like receptors (TLR) are one of the primary mechanisms by which innate immune cells detect and acutely respond to microbial infection. Dysregulation of these signaling pathways has been implicated in the pathology of a variety of inflammatory and autoimmune diseases.

TLR7 normally serves to detect viral single-stranded RNA (like SARS-Cov-2), but it is also linked to cytokine storm development and acute kidney injury in sepsis and lupus. Previous in vitro laboratory investigations have demonstrated that Ampion inhibits activity of pro-inflammatory transcription factors (NF-κB and STAT) and pro-inflammatory cytokine release (such as TNFα, IL1β, IL6, and CXCL10) in a variety of immune cells.

“Recent evidence from our laboratory demonstrates that Ampion treatment of macrophages and peripheral blood monocytes stimulated with a specific TLR7 activator significantly inhibits the release of CXCL10, the chemokine associated with the dysregulated immune response seen in COVID-19,” said David Bar-Or, M.D., Director and Founder of Ampio Pharmaceuticals and a co-investigator in the study. “Ampion reduced CXCL10 up to 92 percent compared to a saline solution (p<0.05). This result also implies a role for Ampion in inhibiting the upregulated TLR7 signaling shown in the devastating kidney complication of systemic lupus erythematous, lupus nephritis, for which no specific treatment is available.”

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.

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