hVIVO, a subsidiary of the specialist contract research organisation, Open Orphan, has signed a £5m influenza human challenge study contract with an unnamed biotechnology company developing an antiviral drug for protection against respiratory viral infections.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV, malaria, and asthma. In 2020, this expanded to include SARS-CoV-2.

The influenza human challenge study is expected to commence in 2H22 and will test and assess the efficacy of a single dosing regimen of the client’s antiviral drug in healthy adult volunteers using hVIVO’s Influenza human challenge study model, the company explained.

Open Orphan told investors that it expects the majority of revenues from the study to be recognised in 2022. The study will be conducted at hVIVO’s London-based facilities.

Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza, the company explained.

Respiratory tract infections are infections of parts of the body involved in breathing, such as the sinuses, throat, airways or lungs and are often caused by viruses such as influenza. 

‘Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health problem. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year,’ Open Orphan told investors.

Commenting on this morning’s contract win, Cathal Friel, Executive Chairman of Open Orphan, outlined: “We are delighted to be working with this biotech client to assess the efficacy of their antiviral product which has the potential to be an important treatment against respiratory viral infections, using the hVIVO Influenza human challenge study model.”

He commented: “We have now signed contracts for 95% of our 2022 forecasted revenues. This is the fourth Influenza human challenge study that we have signed in 2021 and coupled with the contract wins that we have seen in other disease areas, this further underlines the growing interest in respiratory and infectious diseases within the pharmaceutical and biotechnology industries, which we expect to continue over the coming years.”

He added, “Additionally, the continued damaging effects of the COVID-19 pandemic have underlined the need for increased pandemic preparedness in relation to other potential pandemic infectious diseases, such as influenza. Our expertise in testing vaccines and antivirals against our portfolio of infectious disease human challenge models will be important in ensuring we are prepared for the next, potentially more dangerous pandemic disease.” 

In recent weeks, hVIVO signed a $13.4m contract with a US-based biotechnology firm to test its novel antiviral candidate using the hVIVO Influenza Human Challenge Study Model.  

The study is expected to commence in H2 2022 and will be conducted at hVIVO’s quarantine facilities in London, with the majority of these revenues expected to be recognised in 2022.

The Company acknowledged that the ongoing coronavirus pandemic has highlighted the increased investment needed from governments and Big Pharma to develop effective, novel treatments for a range of infectious diseases that have potential to cause the next pandemic. 

As a result, hVIVO said it expects to sign an increasing number of contracts in this area. Open Orphan noted that the infectious disease market is expected to be worth $250 billion by 2025.

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