hVIVO (HVO ), a specialist contract research organisation, has announced a £6.8m contract with a pharma client based in Asia-Pacific to test its respiratory syncytial virus (RSV) antiviral drug candidate.
hVIVO will conduct a Phase 2a double-blinded human challenge trial at its quarantine facilities in Whitechapel to evaluate the efficacy profile of the antiviral against RSV. The study is expected to commence in H1 2024 with revenue mostly recognised in 2024.
This marks the second human challenge trial that hVIVO has signed with an Asia Pacific client in 2023, following January's £5.2m contract with an APAC-based global biotech company to test another RSV vaccine candidate, its first in the region.
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Markets welcomed hVIVO's second APAC contract, sending HVO shares up 17% this morning. hVIVO has identified APAC as a key growth area and stated its goal to attract more customers from the region. The company is delivering on its objective, having now signed two RSV vaccine contracts with APAC-based clients, worth collectively £12m in less than a month.
Over the past year, hVIVO has scored 12 contracts worth approx. £77.4m, a 60% increase compared to the 7 contracts signed in 2021 worth £48.3m. The company's recent stock performance reflects this momentum, with HVO up 91% in the past 6 months, and up 68% so far this year.
More and more pharma and biotech companies are trusting hVIVO's model as they learn about the benefits of human challenge trials. Four of the top ten global biopharma companies are now regular clients of hVIVO.
This growth is being driven by increasing demand for human challenge services in a rapidly expanding infectious and respiratory disease clinical trials market. Since the Covid-19 pandemic, there has been a marked increase in the number of companies looking to test vaccines and antivirals against specific subtypes of viruses that have the potential to be widely spread. APAC is an exceptionally fast-growing market for clinical trials, with over 8,000 started in the region in 2021.
RSV in particular affects an estimated 50 million people annually, leading to 4 million hospitalisations and approximately 60,000 in-hospital deaths in children younger than five years. RSV has indeed strained health care systems in the US and Europe this winter, with reports suggesting newborns are being hospitalised in the US at seven times the rate observed in 2018.
Human challenge studies provide great value for biopharma companies as they offer access to fast and cost-effective data that enables easy decisions ahead of larger Phase 2 studies. This gives companies the best possible chance of quickly advancing their candidates through the development pathway. hVIVO has already inoculated over 1,600 volunteers across 28 RSV challenge trials, expediting development of RSV vaccines.
hVIVO's momentum in APAC and globally is expected to continue. The company already has at least 95% of its FY23 revenue target contracted. Therefore, we expect hVIVO to meet or exceed FY23 market forecasts, with today's contract further strengthening its revenue visibility into 2024.
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