Benzinga | Jul 23, 2020 08:06AM EDT

Ampio Pharma Reports Initiation Of Patient Enrollment In Ampion Coronavirus Program

Ampio Pharmaceuticals, Inc. (NYSE: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") AmpionTM 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 (TNF?), by repressing their transcription. Proinflammatory cytokines like TNF? 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 ( 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.