AIM ImmunoTech has announced a planned Phase 2a human challenge trial of intranasal Ampligen rintatolimod against human rhinovirus and influenza. The company suggested that “Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses.” The trial is expected to begin in the fourth quarter of 2021 and will be conducted by Open Orphan subsidiary hVIVO.
In April 2021, AIM Immunotech announced positive results from a Phase 1 trial of intranasal Ampligen. The company is also developing an inhaled formulation of Ampligen for the treatment of COVID-19.
AIM CEO Thomas K. Equels said, “It is our belief that Ampligen’s mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a human challenge trial using hRV and influenza allows us to test in humans Ampligen’s potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses.”
Open Orphan Executive Chairman Cathal Friel commented, “We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product and to demonstrate our expertise in testing vaccines and antivirals using our world-leading portfolio of human challenge models. While the pandemic has undoubtedly inflicted a lot of loss and suffering globally, it has also taught us a valuable lesson in pandemic preparedness. It is my belief therefore that the infectious disease market has been utterly transformed and is going to grow exponentially in the years ahead. Challenge studies are a key weapon in the arsenal against infectious diseases as they can bring effective treatments and vaccines to the market both quicker and faster than they could otherwise.”
Read the AIM Immunotech press release.
