Research Shows Ampion™ Gene Regulation Mimics the Anti-Inflammatory Effects of Steroids, but without Adverse Effects

ENGLEWOOD, Colo., April 19, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (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 findings of pre-clinical research demonstrating that Ampio's lead drug candidate, Ampion™, provides some of the same anti-inflammatory effects as the steroid dexamethasone but without the significant adverse events associated with steroids.

"Steroids such as dexamethasone are globally immunosuppressive, to both innate and adaptive immune systems, with effects that are beneficial in the short term and often harmful long-term," said David Bar-Or, M.D., Director and Founder of Ampio Pharmaceuticals.

"Our research looked at the gene-level interactions of both Ampion and dexamethasone in immunostimulated peripheral blood monocytes, or PBMCs," continued Bar-Or, "and it became clear that Ampion regulated some of the same inflammation-associated genes as dexamethasone, though through disparate mechanisms of action. This may explain Ampion's ability to mimic the anti-inflammatory effects of steroids without causing similar adverse effects."

Michael Macaluso, President and CEO of Ampio, commented, "The coronavirus pandemic has highlighted the critical need for medical innovation. The potential availability of an anti-inflammatory therapy that provides many of the same benefits of dexamethasone without the similar adverse effects of long-term use would be a boon for patients suffering from debilitating and often life-threatening inflammatory disease."

The research highlighted key similarities and differences between Ampion and dexamethasone.

Similarities between Ampion and Dexamethasone

In the three different immunostimulation conditions used to evaluate Ampion's effect on PBMCs, Ampion regulated 102 of the same transcripts as dexamethasone according to RNA sequencing and differential gene expression analysis performed with Ingenuity Pathway Analysis (IPA) software from QIAGEN Digital Insights.

Further, overall IPA modeling predicted significantly similar regulation of downstream molecules by dexamethasone and Ampion based on directionally correlated transcripts. A comparison showed that, in each immunostimulatory condition, transcripts regulated by Ampion significantly overlapped with transcripts regulated by dexamethasone.

"Ampion acts as an anti-inflammatory drug with some important overlapping effects also provided by dexamethasone," explained Bar-Or.

Differences between Ampion and Dexamethasone

However, there were some significant differences seen between Ampion and dexamethasone. Based on IPA computational modeling, there were 30 transcripts where Ampion's activity was different than known regulation by dexamethasone – up regulating when dexamethasone was down, or vice versa – in at least one of the treatment conditions. Dexamethasone also targets a wide range of molecules that are not regulated by Ampion.

"These observations may help to explain, in addition to the different modes of action of the two drugs, why patients treated with Ampion do not suffer the same adverse effects as those treated with dexamethasone," said Bar-Or.

The absence of significant adverse effects in the large numbers of patients administered Ampion – by intra-articular injection, intravenous administration, and inhalation, and now supported by multi-omics (genomics, transcriptomics, proteomics and metabolomics) analysis and IPA modeling of the Mechanism of Action (MOA) of Ampion compared to corticosteroids, provides an encouraging foundation for the ongoing clinical investigations of Ampion in a wide range of inflammatory conditions.

"In essence," concluded Bar-Or, "this evidence suggests that Ampion is an anti-inflammatory drug with some important overlapping effects provided by dexamethasone but without the significant adverse events associated with steroids."

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a 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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SOURCE Ampio Pharmaceuticals, Inc.

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