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, has announced that hVIVO, a subsidiary of Open Orphan, has signed a £7.2m contract with an existing top 5 global pharmaceutical company to test its orally administered antiviral product, using hVIVO’s respiratory syncytial virus Human Challenge Study Model.
The Phase 2a double-blinded placebo-controlled human challenge study will take place at the Company’s specialist quarantine facilities in Whitechapel and will evaluate the safety and efficacy profile of the antiviral against RSV. The study will commence in June 2022, with the revenue being recognised in 2022 and 2023. As part of the study, hVIVO will recruit healthy volunteers via the Company’s dedicated volunteer recruitment arm, FluCamp.
The client’s antiviral is presently in Phase III clinical trials for another infectious disease indication and the client will use human challenge to assess the efficacy of their antiviral drug candidate against RSV quickly and efficiently, highlighting the value that human challenge studies can bring within the drug development process. The repeat business from this top 5 global pharmaceutical company underlines the Company’s world leading expertise and its ability to attract additional contracts from its existing Big Pharma clients.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “We’re delighted to be working with this top 5 global pharmaceutical client again to test their antiviral candidate using the hVIVO RSV Human Challenge Study Model. I am especially proud that our world-class offering and customer service has secured repeat business from another Big Pharma client, and that we are seen as the ‘go-to’ partner for an increasing number of global drug developers. The client’s drug has already been shown to be an effective antiviral in certain disease indications, and we’re pleased to now test its efficacy against RSV infection. RSV continues to be a serious global health threat causing an estimated 100,000 annual deaths in children under the age of five.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. With a drug that has existing safety data and has been approved for one indication, human challenge studies can provide fast, cost-effective efficacy data within a new indication. The data will then indicate whether the candidate is viable for a wider Phase II study, providing substantial time and financial savings compared to traditional field-based studies.”