hVIVO PLC said it has won a £16.8 million contract to provide its human challenge trial services to test a respiratory syncytial virus (RSV) drug candidate for one of the five largest pharmaceutical companies in the world.
The company announced the contract in a statement that also noted that revenue and earnings (EBITDA) are both expected to be ahead of previous market expectations for the current calendar year.
Some revenue from the RSV contract will be recognised this year, the majority in 2024 and some in 2025, it said, which helps provide “clear revenue visibility” into the new financial year.
Several of the world’s major drug companies are working on RSV candidates, including Pfizer Inc (NYSE:PFE) and GSK PLC (LSE:GSK, NYSE:GSK), while AstraZeneca PLC (LSE:AZN) yesterday made a foray into the area via a £1.1 billion acquisition.
As per the new contract, expedited virus manufacturing activities will begin immediately and are expected to be completed in the first half of next year.
Once this is available, the contract includes a confirmatory challenge cohort in a small number of healthy volunteers via its FluCamp venues.
Assuming that stage is successful and regulatory approvals are received, a full multiple-cohort RSV human challenge trial is expected to be carried out in the second half of next year in the company's new state-of-the-art quarantine facilities in Canary Wharf, which it said are “on track” to be operational in the first half.
This will be a randomised, double-blinded, placebo-controlled Phase 2a study, with the multiple cohorts evaluating the efficacy of the client's RSV candidate via different dosing regimens.
The multiple-cohort study highlights the expanding use of human challenge trials to pharma clients, hVIVO said, as it demonstrates their ability to provide quick efficacy data and also refine dosing strategies ahead of later-stage clinical trials.
Chief executive Yamin 'Mo' Khan said such end-to-end contracts have been successfully provided to several clients before.
"Our RSV (Memphis strain) 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,” he said, adding that the company is working with clients to add new models.
“We are also delighted with the company's strong operational performance in 2023 and now expect to exceed the previous market guidance and look forward to updating the market further in the new year.”