Ampio Pharmaceuticals has started a phase 1 clinical trial in the US for assessing its immunomodulatory anti-inflammatory agent Ampion as a five-day intravenous (IV) treatment for COVID-19 in adult patients who need supplemental oxygen.
According to the Colorado-based biopharma company, the primary endpoint for the randomized, controlled study – NCT04456452 is the safety and tolerability of the immunomodulatory anti-inflammatory agent.
As per the information available on Clinicaltrials.gov, the NCT04456452 clinical trial is expected to enroll 10 participants.
Ampion has been proven to inhibit the expression of proinflammatory cytokines, including tumor necrosis factor alpha (TNFα), by subdue their transcription, said Ampio Pharmaceuticals.
The US biopharma company said that proinflammatory cytokines such as TNFα are thought to play an important role in the overactive inflammatory response, or cytokine storm, in the lungs of patients with COVID-19 who need supplemental oxygen.
Dr. Michael Roshon from Penrose-St. Francis Hospital in Colorado Springs, who is the Principal Investigator of the NCT04456452 clinical trial, commenting on the early-stage study of Ampion, said: “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.”