Study cohort sizes increase as clients recognise the benefits of human challenge
hVIVO plc (AIM & Euronext: HVO) (formerly Open Orphan plc), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that it has signed a £13.6m 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 the Company’s specialist quarantine facilities in Whitechapel and will evaluate the efficacy profile of the antiviral against RSV infection. The study is expected to commence in Q3/Q4 2023, with the revenue being recognised in 2023 and 2024. As part of the study, hVIVO will recruit healthy volunteers via the Company’s dedicated volunteer recruitment arm, FluCamp .
This contract highlights hVIVO’s world leading expertise in its field and its ability to execute sizable contracts as well as the industry’s renewed focus on developing new treatments for RSV. The Company continues to see growing demand for larger challenge studies from both new and existing clients as they seek greater clarity of data and pursue lower frequency endpoints in an effort to further de-risk their programmes ahead of later stage field studies.
Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, 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.”
Alex Mann, Senior Director 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.
“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.”
For further information please contact:
+44 (0) 20 7756 1300
Yamin ‘Mo’ Khan, Chief Executive Officer
Stephen Pinkerton, Chief Financial Officer
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