UK trials contractor hVIVO has signed a £16.8 million ($21.5 million) full-service contract with a “top five global pharmaceutical client” to test a developmental respiratory syncytial virus (RSV) antiviral.
According to a financial filing, the contract will see London-based firm use the antiviral drug – details of which were not provided – using its RSV Human Challenge Study Model in a multiple cohort challenge trial.
The aim is to evaluate the efficacy of the antiviral candidate against RSV in healthy adults and identify the most effective dosing ahead of later stage clinical trials.
The contract also includes the expedited manufacturing of the RSV challenge agent. hVIVO will commence Good Manufacturing Practice (GMP) compliant virus manufacturing activities immediately, which is expected to complete in H1 2024.
Upon completion of manufacturing, the firm expects to confirm infectivity of the new RSV challenge virus batch in small number of healthy volunteers recruited via FluCamp, a patient and hospital network focused on boosting study participation.
The clinical research organization (CRO) said revenue from the contract will be recognised across 2023, 2024 and 2025 with the majority of the revenues being recognised in 2024.
Subject to the completion of the manufacturing phase, and the receipt of relevant regulatory approvals, hVIVO expects to start a randomised, double-blinded, placebo-controlled Phase IIa study of the candidate in the second half of next year. The trial will be based at the new unit the CRO is building in Canary Wharf, London.
CEO Yamin Khan, said: "Our RSV challenge agent has played a significant role in the development of RSV vaccines and we are delighted that it is continuing to be used as the go-to model for our clients. This contract is another example of the end-to-end full service offering that hVIVO has already successfully provided to several clients.”
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