Open Orphan plc (LON:ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced that hVIVO, a subsidiary of Open Orphan, has signed a £7.3m influenza human challenge study contract with a leading biotechnology company to test its antiviral product using the 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 Study will be conducted by hVIVO’s team of medics at its state-of-the-art quarantine facilities in London and is expected to commence next year. Revenue from the contract is expected to be recognised across FY23 and FY24.
The Company’s specialised virology laboratories, hLAB, will determine the viral load of the influenza challenge agent used to inoculate volunteers, hLAB will also provide serology services and virology services (viral infectivity assay) for the study.
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 Financial Times1 analysis of official data in England, 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.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “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.
“Since the advent of effective vaccines and treatments for COVID-19, there has been renewed focus on influenza and official data shows flu is now a more lethal threat. After completing the study, we hope to provide positive data and early proof of concept for our client’s product, in order to accelerate its development into a Phase II programme.”
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to sign a contract with this leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. 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.”
1‘Vaccines and Omicron mean Covid now less deadly than flu in England’, The Financial Times, by Burn-Murdoch, John, and Barnes, Oliver. Link: https://www.ft.com/content/e26c93a0-90e7-4dec-a796-3e25e94bc59b