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Highlights
- hVIVO signs £11.5 million contract with a leading global pharmaceutical client for an RSV challenge trial.
- The trial will evaluate an antiviral candidate's safety, pharmacokinetics, and activity, leveraging hVIVO’s FluCamp recruitment arm.
- The RSV challenge model has accelerated the development of several drug and vaccine candidates.
hVIVO plc (LSE:HVO), a specialist contract research organisation (CRO) renowned for its expertise in testing infectious and respiratory disease products through human challenge clinical trials, has signed an £11.5 million contract with an existing top-tier global pharmaceutical client. The contract will see hVIVO conduct a Phase 2a human challenge trial to evaluate an antiviral drug candidate using its proprietary Respiratory Syncytial Virus (RSV) Human Challenge Study Model.
The Phase 2a trial will be randomised, double-blinded, and placebo-controlled, designed to assess the safety, pharmacokinetics, and antiviral activity of the client’s drug candidate. The trial will be conducted at hVIVO's advanced quarantine facilities in Canary Wharf and is scheduled to begin in the second half of 2025. Revenue from the contract is expected to be recognised across 2025 and 2026.
This repeat contract demonstrates the continued value global pharmaceutical companies place on hVIVO’s human challenge trials. These trials offer a fast and cost-effective way to gather early-stage human efficacy data, which can significantly inform the design of later-stage trials and accelerate the development timeline for new therapies.
Respiratory Syncytial Virus (RSV) remains a leading cause of lower respiratory infections in children and a major health burden in the elderly and adults with chronic conditions like COPD. RSV affects an estimated 33 million people globally each year, leading to millions of hospitalisations and thousands of deaths in children under five. Despite recent advancements in RSV vaccines, there is still a significant unmet need for effective antiviral treatments, particularly for acute disease.
hVIVO has a long track record in RSV challenge studies, having inoculated approximately 2,000 healthy volunteers in around 30 RSV challenge trials. These trials have helped expedite the development of several RSV drug and vaccine candidates. Notably, hVIVO's RSV challenge model has provided pivotal proof-of-concept data that has led to product acquisitions and regulatory designations such as FDA Fast Track and Breakthrough Designations. Additionally, one of the RSV products tested using this model has now been launched to market.
