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Ampio Publication Reports Beneficial Effects of Ampion on Important Transcription Factors in Inflammation

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Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced the publication of a preprint report demonstrating that Ampion™ reduces pro-inflammatory cytokine release by modulating inflammatory transcription factors. The findings suggest Ampion suppresses crucial pathways, indicating its potential anti-inflammatory effects, particularly in conditions like severe COVID-19. The manuscript supports safety and tolerability observed in prior trials. Ampion has a robust patent portfolio and could receive 12-year FDA market exclusivity upon approval as a novel biologic.

Positive
  • Ampion demonstrated ability to reduce pro-inflammatory cytokine release, suggesting strong anti-inflammatory properties.
  • Publication adds evidence of Ampion's efficacy in treating inflammatory conditions, including severe COVID-19.
  • The safety profile of Ampion shows no serious drug-related adverse events in clinical trials.
  • Ampio holds an extensive patent portfolio with protection extending through 2032.
Negative
  • Future FDA approvals for Ampion remain uncertain and subject to regulatory risks.

ENGLEWOOD, Colo., Oct. 8, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the publication of a scientific manuscript on Ampion™ effects on peripheral blood monocytes ("PBMC") in a preprint report (Ampion suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC, DOI: https://doi.org/10.21203/rs.3.rs-86515/v1).

In this report, evidence is provided that Ampion reduces pro-inflammatory cytokine release by activating the immunoregulatory transcription factors PPARγ and AhR. In addition, data indicates that Ampion suppresses NF-κB and STAT1α pro-inflammatory pathways, suggesting that Ampion acts through these mechanisms to decrease pro-inflammatory transcription factor activity and subsequent inflammatory cytokine production.

This publication adds to the growing evidence of the important anti-inflammatory activities of Ampion in various inflammation related conditions, including the dysregulated immune response observed in severe COVID-19 infected patients. A recurring theme across all clinical trials with Ampion, including our recent Phase I trial for intravenous ("IV") Ampion treatment for COVID-19 patients, is that this anti-inflammatory biologic has been safe and well-tolerated with no serious drug related adverse events. https://ampiopharma.com/news/ampio-reports-positive-results-in-early-trial-for-iv-ampion-treatment-in-covid-19-patients/  

About Inflammatory Diseases                                                                                           Inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect. 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 plays a major role in many disease processes including allergy, asthma, autoimmune disorders such as hepatitis, inflammatory bowel disease, transplant rejection and more.

About Ampio Pharmaceutical
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.

Company Contact
Dan Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-publication-reports-beneficial-effects-of-ampion-on-important-transcription-factors-in-inflammation-301148667.html

SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What did Ampio Pharmaceuticals announce on October 8, 2020 regarding Ampion?

Ampio announced the publication of a preprint report showing Ampion's effects in reducing pro-inflammatory cytokine release, indicating potential benefits in inflammatory diseases.

How does Ampion reportedly work in inflammatory conditions?

Ampion is said to reduce cytokine release by modulating inflammatory transcription factors and suppressing key inflammatory pathways.

What is Ampio Pharmaceuticals' focus in the biopharmaceutical industry?

Ampio focuses on developing immunology-based therapies, particularly the drug Ampion for treating prevalent inflammatory conditions.

What are the regulatory prospects for Ampion?

If approved as a novel biologic, Ampion could receive 12-year FDA market exclusivity under the biologics price competition and innovation act.

What clinical outcomes have been observed with Ampion in trials?

Ampion has been noted for its safety and tolerability, with no serious drug-related adverse events reported in clinical trials.

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