Open Orphan wins significant HRV & Influenza human challenge study contract

Open Orphan

Open Orphan plc (LON:ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, has announced that hVIVO, a subsidiary of Open Orphan plc, has signed a significant contract with AIM ImmunoTech Inc to test its antiviral candidate, Ampligen, using both the human Rhinovirus HRV (common cold virus) and Influenza human challenge study models as part of a single study.

This antiviral study will be conducted by hVIVO. AIM IT will be the study sponsor of the Phase 2 human challenge trial, which is expected to commence in Q4 2021. The Company expects the majority of revenue from the contract to be recognised in the current financial year. The AIM IT contract demonstrates the breadth of Open Orphan’s service offering and its ability to test multiple pathogens at once in its state-of-the-art zoned unit, reinforcing its status as the world leader in its field. The Company expects to sign more contracts in this area due to the increased international focus on respiratory and infectious diseases following the outbreak of COVID-19 and as attention turns to potential future outbreaks of other viral diseases.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus). In October 2020, this expanded to include the SARS-CoV-2 virus.

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 Inc., 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.”

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