hVIVO, a subsidiary of Open Orphan (ORPH ), has signed a £5m respiratory syncytial virus (“RSV”) human challenge study contract with a European biotechnology company to test its intravenous antiviral candidate, using the hVIVO RSV Human Challenge Study Model.

The human challenge study is expected to commence this year and will test and assess the efficacy of the client’s antiviral candidate in a cohort of healthy young adult volunteers. The Company expects the revenues from the contract to be recognised across 2022 and 2023.

Open Orphan said the contract builds on its existing relationship with this biotech, following previous early clinical work completed by Venn Breda team, thereby highlighting its ability to maintain relationships with its clients over time and to cross sell services between brands.

The study will be conducted by hVIVO’s medical team at its London-based quarantine facilities which was recently expanded from 43 to 62 beds, an increase of around 45%.

The Company said its specialised virology laboratories, hLAB, will provide qPCR (quantitative polymerase chain reaction), infectivity and serology data for this human challenge study.

Healthy volunteers for the study will be recruited through the Company’s volunteer recruitment arm, FluCamp. This arm was also recently expanded across its screening facilities in London and Manchester to enable larger cohorts to be recruited more quickly than before, it noted.

The new facilities opened in Manchester expands its reach to facilitate the increasing demand for human challenge studies, allowing it to recruit volunteers beyond the greater London area.

As a result, the company told investors that it is now even better equipped to identify volunteers and to complete its growing pipeline of studies in a time efficient manner.

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated

50-million people annually, leading to 4 million hospitalisations and up to 75,000 in-hospital deaths in children under the age of 5 years.

Open Orphan recognises the lack of understanding and insight into RSV disease, ‘especially in adult groups, despite its considerable impact on society and its high degree of infectivity.’

Commenting, Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to announce this £5m contract to test our client’s antiviral candidate using the hVIVO RSV Human Challenge Study Model. RSV is a significant threat to public health, and we are delighted to support this European biotech in the development of its antiviral candidate.

“Leveraging my extensive CRO experience, I look forward to continuing to drive further contract wins across our portfolio of infectious and respiratory disease challenge models.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a further demonstration of the significant value of human challenge studies. Efficacy data provided by the Company following the completion of the study can lead to entry into Phase II as well as optimisation of a Phase III programme. For Big Pharma as well as smaller biotechs, the substantial time and financial savings compared to typical field-based studies is increasingly making human challenge the trial design of choice for achieving early proof of concept data.”

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