Biopharmaceutical company Ampio Pharmaceuticals Inc (NYSE American:AMPE) on Monday announced a new global clinical trial for intravenous (IV) treatment of Ampion for COVID-19 in Israel and the US, as well as provided update of its ongoing US trial for inhalation treatment of COVID-19.
The company added the Ampion IV treatment targets systemic inflammation in the body of patients with moderate to severe COVID-19 symptoms. The study will assess the effect of Ampion IV treatment in both a hospital setting and as a therapy for out-patient care.
According to the company, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The multiple human clinical trials is focusing on patient safety and efficacy, as measured by improvement in the clinical course of the disease and related outcomes for patients with moderate to severe COVID-19.
A Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. The company's trial is currently ongoing with no drug-related serious adverse events (SAEs) reported to date. The rate of enrollment is expected to increase once requisite front-line workers receive the recently released COVID-19 vaccines.
In addition, the company's inhaled Ampion targets inflammation in the lung and is being investigated to determine whether its use will improve the clinical outcome for patients with COVID-19. Of note, there have been no drug-related SAEs to date in the inhaled clinical trial.
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