hVIVO PLC (formerly Open Orphan) has signed a £13.6mln contract with a US-based biopharmaceutical client to test its respiratory syncytial virus (RSV) antiviral candidate, using hVIVO's established RSV Human Challenge Study Model.
The phase 2a double-blinded placebo-controlled human challenge trial will take place at hVIVO’s specialist quarantine facilities in Whitechapel, London and will evaluate the efficacy profile of the antiviral against RSV infection.
Alex Mann, senior director of clinical science of hVIVO said: "RSV continues to be a serious global health threat causing an estimated 100,000 annual deaths in children under the age of five and we are currently seeing a significant jump in cases around the world as we enter the winter months.”
The company said it will recruit healthy volunteers for the trial from its dedicated volunteer recruitment arm, FluCamp.
Commenting on the contract, hVIVO chief executive officer Yamin 'Mo' Khan said: "We're delighted to be working with this biopharma client to test their antiviral candidate using our established hVIVO RSV Human Challenge Study Model.”
“We continue to see an increase in the size of our studies as new benefits of challenge study data are continually realised by both new and existing biotech and pharma clients."
Mann added: "This contract is a strong example of where human challenge studies can provide great value for our clients, with access to fast, cost-effective efficacy data which can provide a 'go/no-go' decision ahead of a larger phase 2 study, allowing our clients to ensure that their candidates have the best possible chance of advancing through the rest of the development pathway."
The company expects the study to start in the third or fourth quarter of 2023, with the revenue being recognised in 2023 and 2024.