Open Orphan’s hVIVO signs £7.3m influenza study contract
hVIVO, a subsidiary of the contract research organisation Open Orphan (ORPH), said it has signed a £7.3m influenza human challenge study contract with a leading biotechnology firm to test its antiviral product using its own hVIVO Influenza Human Challenge Study Model.
The randomised, double-blinded, placebo-controlled study will test and assess the antiviral prophylactic and post-inoculation treatment activity of the antiviral in healthy adult volunteers enrolled through the Company's specialist, tech-enabled volunteer recruitment arm, FluCamp.
The influenza human challenge study will be conducted by hVIVO's team of medics at its London-based quarantine facilities and is expected to commence next year. The company detailed that revenue from the contract is expected to be recognised across FY23 and FY24.
hVIVO’s specialised virology laboratories - also known as hLAB - which will provide serology services and virology services (viral infectivity assay) for the human challenge study, will be used to determine the viral load of the influenza challenge agent used to inoculate volunteers.
Influenza is a contagious respiratory illness caused by influenza viruses that affect the nose, throat and the lungs. It can cause mild to severe illness, and occasionally lead to death.
According to an analysis of official data in England by the Financial Times, since the development of effective vaccines and the emergence of the less severe Omicron variant, influenza is now more lethal than COVID-19. For every 100,000 Omicron infections, 35 will result in death, while the equivalent number of flu infections will lead to around 40 fatalities.
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, commented: "hVIVO has seen a steady increase in flu studies, a reflection of the shift in market sentiment following recent scrutiny of infectious disease data that has outlined the significant threat of flu and the potential of human challenge studies to the advancement of drug development candidates."
Dr Andrew Catchpole, CSO of hVIVO, also commented: "We are excited to test the antiviral prophylactic and post inoculation treatment activity against flu infection using the hVIVO Influenza Human Challenge Study Model. hVIVO has pioneered influenza human challenge studies for decades, with our history dating back to the Salisbury Common Cold Clinic.
After completing the study, hVIVO hopes to provide positive data and early proof of concept for its client's product, “in order to accelerate its development into a Phase II programme."
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hVIVO, which has seen a steady increase in flu studies over the past 18 months and given the pandemic potential of the flu, expects to see a steady increase of such challenge studies.
Following hVIVO’s recent facility expansions, the business can now offer its services beyond the core challenge study offering such as the recently announced vaccination site contract.
The company detailed today that revenue from the influenza human challenge study contract is expected to be recognised across FY23 and FY24 - “something the company has never done before in the past,” Co-Founder and Executive Chairman, Cathal Friel tells investors.
As such, the company said it has a major backlog of work stretching “into the coming years.” Shares in Open Orphan were trading 7.02% higher during early morning trading at 15p.
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