Open Orphan to commence influenza human challenge study




Candidate exhibits a novel mechanism of action and differs considerably from previously approved drugs

Open Orphan – a specialists in testing infectious and respiratory disease products using human challenge clinical trials – has announced that its subsidiary, hVIVO, has signed a £6.2m contract with a US-based biotechnology company to test its antiviral candidate.

‘The human challenge study’ is expected to commence in 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.

Preliminary data has already been published to demonstrate a favourable pharmacokinetic and safety profile, while the candidate also exhibits a novel mechanism of action and differs considerably from previously approved drugs.

This represents the third significant influenza human challenge study contract that Open Orphan has signed in 2022, as attention switches to potential future outbreaks in this specific disease area. Influenza remains a serious global health threat with an estimated one billion cases per year and around 290,000 to 650,000 deaths per year.

Yamin Khan, chief executive officer of Open Orphan, reflected: “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 $5.5bn 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,” he added.

hVIVO has three decades of experience in safely conducting challenge studies across a range of respiratory viruses, including strains of influenza, respiratory syncytial virus, asthma and malaria. In June 2022, hVIVO revealed that it is developing the world’s first SARS-CoV-2 Omicron human challenge model.



Source link