Ampio Pharmaceuticals, a US-based company offering a range of immunology-based therapies for inflammatory conditions, has launched a clinical trial to test Ampion (administered intravenously) to treat COVID-19. In addition, the company reports it plans to expand its Phase I trial testing an inhaled version of the drug to treat the virus.
Michael Macaluso, chair and CEO of Ampio Pharmaceuticals, said the approval and rollout of vaccines is a positive step, treatments still are very much needed.
"While the vaccine will hopefully help many people avoid the more serious complications of COVID-19, the rollout of vaccines will take time and is unlikely to ever reach 100% of the public," he said. "We will no doubt continue to need treatments to provide the essential relief and improve outcomes for patients, and we are especially excited to begin the testing of Ampion for COVID-19 in an outpatient setting."
According to the company, Ampion can be used to interrupt the hyper-active immune response known as cytokine storm, frequently associated with serious COVID-19 symptoms. A range of various drugs are being explored to treat this COVID-related phenomenon.
A global study (initiated in the US and Israel) has been launched, with the intent to focus on patient safety and drug efficacy, as measured by improvement in the course of the desease and patient outcomes for people with moderate to severe COVID-19. The IV treatment targets inflammation in the body, and the study is intended to assess the effect of Ampion IV treatment in both hospital settings and outpatient care.
Additionally, a US-based Phase I trial, exploring the viability of inhaled Ampion, is being expanded to additional hospitals; Ampio Pharmaceuticals reports that to date, no drug-related serious adverse events have been reported in the ongoing research. The company plans to increase enrollment as frontline workers receive the vaccines, with the goal to conclude enrollment in January.
In addition to clinical trials sponsored by pharmaceutical firms, the National Institutes of Health (NIH) launched a Phase III trial in October, designed to examine the viability of using immune modulators to treat hospitalized COVID-19 patients. The research aims to determine if focusing on immune response in such a way can reduce the length and severity of the disease, and to cut down the need for use of ventilators.