Specialist contract research organisation Open Orphan said its hVivo subsidiary has signed a new £7.2 million (€8.4 million) contract with a global pharmaceutical company to test its antiviral drug using hVivo’s respiratory syncytial virus (RSV) challenge study.
The study, which is double-blinded and placebo-controlled, will evaluate the safety and efficacy of the antiviral against RSV. It will be conducted at hVivo’s specialist quarantine facilities in London, starting in June 2022, recruiting healthy volunteers through the company’s dedicated volunteer recruitment arm, FluCamp.
“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,” said Dr Andrew Catchpole, chief scientific officer of hVivo. “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.”
Revenue from the deal will be recognised both this year and in 2023.
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“We’re delighted to be working with this top-five 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,” said Open Orphan chief executive Yamin ‘Mo’ Khan. “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 is estimated to cause around 100,000 deaths per year in children under five. Open Orphan was previously involved in research for Bavarian Nordic’s vaccine candidate for RSV, for which the US Food and Drug Administration granted breakthrough therapy designation in February. HVivo conducted a Phase II, double-blinded, placebo-controlled human challenge trial to assess the vaccine candidate, providing a significant portion of preliminary evidence.
Open Orphan, a European-focused, rare and orphan drug consulting services platform, is the result of executive chairman Cathal Friel reversing his pharma services business of the same name into Dublin-listed drug clinical trials manager Venn Life Sciences.
