Clinical research organisation (CRO) Open Orphan has announced that its subsidiary hVIVO has signed a contract with AIM ImmunoTech to test its antiviral candidate, Ampligen, against the human Rhinovirus HRV, or common cold, and influenza, in a single human challenge study model.
AIM ImmunoTech, a biopharmaceutical company, will sponsor the Phase 2 human challenge trial, which will be conducted by hVIVO. The study is expected to start towards the end of 2021 and hVIVO is looking at signing more contracts in the area of respiratory and infectious diseases following the outbreak of Covid-19.
Cathal Friel, executive chairman of Open Orphan, said: “We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product against both HRV and Influenza human challenge study models as part of a single study. Being able to test our client’s product against multiple pathogens in a single study demonstrates our capability of our state-of-the-art London unit, our industry leading experience, and our position as the go to provider of human challenge studies for biotech and pharmaceutical companies globally. Fortunately, with our access to three challenge study clinics in London, we were able to find a small gap in our schedule later this year to slot this particular study in at short notice.
“Likewise, as previously confirmed to the market, our London facilities are comprehensively prebooked throughout this year and into next year. As such, I am also delighted to confirm that we were solidly EBITDA profitable in H1 2021 and we remain on target for a profitable and successful 2021.”
Thomas K. Equels, chief executive officer of AIM ImmunoTech, 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.”