Open Orphan plc (LON:ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, today announced that hVIVO, a subsidiary of Open Orphan plc, has signed a £6.2m contract with a US-based biotechnology company to test its antiviral candidate using the hVIVO Influenza A human challenge study model.
The human challenge study is expected to commence in H2 2022 and will be conducted at hVIVO’s state-of-the-art facilities in London. The Company expects the revenue from the contract to be recognised across 2022 and 2023.
The client has already published preliminary data to demonstrate a favourable pharmacokinetic and safety profile. This candidate exhibits a novel mechanism of action and differs from previously approved drugs. This is an ideal time in the development of this drug to conduct a challenge study.
This is the third significant influenza human challenge study contract that Open Orphan has signed in 2022, as attention switches to potential future outbreaks in this particular disease area. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.
hVIVO has three 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), and asthma, as well as malaria. In June 2022 , hVIVO announced that it is developing the world’s first SARS-CoV-2 Omicron human challenge model.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “We are pleased to be working with this US-based client to test its exciting lead influenza antiviral using our Influenza human challenge study model. That the client has chosen us to run this study is testament to our position as the world leader in testing infectious and respiratory disease vaccines and antivirals using challenge studies. Furthermore, the contract underlines the increasing demand in the infectious disease clinical trial market, which is expected to grow to a value of over $5.5 billion by 2027.
“With this increasing demand in mind, we expect to continue to see our work coming from a broad range of infectious and respiratory diseases, and from companies ranging from smaller innovative biotechs to Big Pharma. “