Dublin-listed pharmaceutical services company Open Orphan has won a £14.7 million (€17.25m) contract to carry out a major influenza study and a follow-on influenza human challenge study with one of its pharmaceutical clients. This follows a challenge virus manufacturing contract signed with the same client, announced this month, the company said. It will be conducted in conjunction with Open Orphan subsidiary hVivo.
“Following completion of the challenge agent manufacturing, the characterisation study will identify a dose of the flu challenge agent that causes a safe and reliable infection in healthy volunteers,” it said.
Subject to the relevant regulatory approvals, the study will start in the third quarter of 2022 and will enrol volunteers recruited from the company’s clinical trial volunteer recruitment arm FluCamp.
Yamin “Mo” Khan, chief executive of Open Orphan, said: “This is another important milestone for hVivo in that, in addition to the previously announced manufacture of a bespoke challenge agent, we have now been contracted to conduct the characterisation and the challenge studies with this big pharma customer.”
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“Moreover, we will also be providing full recruitment and laboratory services. This highlights hVivo’s unique full-service offering in running complex human challenge studies. Our team has a long history of manufacturing challenge agents and conducting human challenge studies. In regard to challenge studies our experience is unrivalled, our scientific expertise unmatched, and our operational delivery in a class of its own,” he said.
