Ampio Starts Patient Enrollment in its Ampion COVID-19 Program

Rhea-AI Summary

Ampio Pharmaceuticals (NYSE American: AMPE) is advancing its immunology-based therapies with a focus on treating COVID-19. The company has initiated a Phase 1 clinical trial to evaluate the safety and tolerability of its intravenous treatment, Ampion™, for patients requiring supplemental oxygen. This trial aims to assess Ampion's efficacy in addressing the overactive inflammatory response seen in COVID-19 patients. With significant patent protection extending to 2032 and potential FDA market exclusivity, Ampio is positioned to explore promising therapeutic targets amidst the ongoing pandemic.

Positive

• Initiated Phase 1 clinical trial for Ampion treatment in COVID-19 patients.
• Ampion shows potential to inhibit proinflammatory cytokines, addressing cytokine storm.
• Extensive patent portfolio with protection until 2032.
• Possible 12-year FDA market exclusivity under BPCIA upon approval.

Negative

• None.

ENGLEWOOD, Colo., July 23, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company" or "Ampio"), is a biopharmaceutical company focused on the development and advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the Company is actively working on the development of therapies for patients infected with the SARS-CoV-2 virus ("COVID-19").

Patients are being dosed in a Phase 1 United States based clinical trial evaluating a 5-day intravenous ("IV") Ampion^TM treatment for COVID-19 patients requiring supplemental oxygen. The primary endpoint for this randomized, controlled study will evaluate the safety and tolerability of IV Ampion treatment in adult COVID-19 patients requiring oxygen supplementation. Additional details of the trial can be found on ClinicalTrials.gov (NCT04456452).

Ampion is an immunomodulatory anti-inflammatory agent that has been shown to inhibit the expression of proinflammatory cytokines, including tumor necrosis factor alpha (TNFα), by repressing their transcription. Proinflammatory cytokines like TNFα are believed to play a key role in the overactive inflammatory response, or cytokine storm, in the lungs of COVID-19 patients who require supplemental oxygen. Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improve the clinical course and outcome of patients. A manuscript detailing this mechanism of action titled, "The novel immunomodulatory biologic LMWF5A (Ampion) for pharmacological attenuation of the "cytokine storm" in COVID-19 patients: a hypothesis", has been published in a peer-reviewed journal ( 1186%252Fs13037-020-00248-4&a=10.1186%2Fs13037-020-00248-4" rel="nofollow">10.1186/s13037-020-00248-4).

"Our understanding of COVID-19 continues to evolve, and we are pleased to partner with Ampio in this trial to assess Ampion's potential as a treatment in the fight against COVID-19. It is clear that modulation of the immune response to COVID-19 is one of the most promising therapeutic targets.  We are very interested in investigating Ampion's effect on inflammation in this setting," said trial Principal Investigator Dr. Michael Roshon, MD, PhD, Chief of Staff at Penrose-St. Francis Hospital in Colorado Springs, Colorado.

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.
AMPE

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What is the purpose of Ampio Pharmaceuticals' Phase 1 trial for AMPE?

The trial aims to evaluate the safety and tolerability of Ampion treatment in COVID-19 patients requiring oxygen.

When was the Phase 1 trial for Ampion treatment initiated?

The patient enrollment in the Phase 1 trial started on July 23, 2020.

How does Ampion treat COVID-19 according to the press release?

Ampion may interrupt the inflammatory cascade associated with COVID-19 by inhibiting proinflammatory cytokines.

What are the potential benefits of Ampion's patent portfolio?

The patent portfolio provides protection until 2032 and potential 12-year market exclusivity from the FDA upon approval.

Where can I find more information about the Phase 1 clinical trial for AMPE?

Details can be found on ClinicalTrials.gov under the identifier NCT04456452.