Ampio Pharmaceutical's Application to the FDA for a Clinical Study of Ampion™ to Treat COVID-19 Induced Acute Respiratory D...

ENGLEWOOD, Colo., April 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions announced today that it was featured on a FOX segment titled, "Englewood pharmaceutical company looking to treat COVID-19 patients with anti-inflammatory drug," reported by an affiliated television station in Denver, Colorado. The primary cause of death associated with SARS-Cov-2 ("COVID-19") infection is Acute Respiratory Distress Syndrome ("ARDS"), and there are no approved treatments for ARDS or COVID-19. The segment featured the Company's application to the FDA to study the treatment of COVID-19 induced ARDS with nebulized Ampion.

To view the FOX video segment in its entirety please visit the link below. Additional information about the potential suitability of the anti-inflammatory properties of Ampion being used for this clinical indication (ARDS) is included in a companion white paper summary titled, "Rationale and scientific evidence for the use of Ampion in the treatment of Acute Respiratory Distress Syndrome secondary to SARS-COV-2," provided in the link below.

• https://kdvr.com/news/coronavirus/englewood-pharmaceutical-company-looking-to-treat-covid-19-patients-with-anti-inflammatory-drug/
  
  
• https://ampiopharma.com/wp-content/uploads/2020/04/01-Apr-2020-Ampion-SARS-COV-2-and-ARDS-Flyer_v4.pdf

Michael Macaluso, Ampio CEO, noted "The Company is exploring options that may enable the completion of the AP-013 study, our Phase 3 clinical trial for the treatment of severe osteoarthritis of the knee, during this COVID-19 pandemic. Simultaneously, we have directed our R&D efforts to explore the possible application of the immunomodulatory and anti-inflammatory properties of Ampion in the most severe and lethal complication of the COVID-19 infected patients: ARDS. The FDA has been very responsive, and the Company is grateful for the Agency's efforts as we work together to study the potential benefits of Ampion in this population."

Enquiries from health professionals and media should be directed via email to [e-mail] 

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.

Company Contact
Dan Stokely, CFO
Phone: [phone]
[e-mail]

 

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SOURCE Ampio Pharmaceuticals, Inc.

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