Open Orphan subsidiary hVIVO has been hired to make H1N1 influenza virus for a Phase IIa study of a developmental antiviral drug.
The UK-based contract research organization (CRO) announced the £10.4 million ($12.1 million) contract this month, sharing few details other than to say that the “top 5 global pharmaceutical client” for which it is making the virus is an existing customer and that this is the third human challenge contract signed with the company.
According to hVIVO, virus manufacture has already started and is expected to be completed in the second quarter next year. The firm also confirmed it will conduct the Phase IIa double-blinded placebo-controlled human challenge study which is expected to be completed by the end of 2023.
The study will evaluate the efficacy profile of the unnamed antiviral against the specific influenza subtype, with the aim being to generate data quickly and efficiently.
hVIVO chief scientific officer Andrew Catchpole said: “This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes.
“The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies,” he continued.
hVIVO has seen a surge in demand for challenge studies in recent years. According to Catchpole “Since the COVID-19 pandemic, the Company has seen an increase in the number of clients looking to test their vaccines and antivirals against specific subtypes of viruses that are circulating in the population or that have the potential to be widely spread.
“As a result, there is a greater interest in end-to-end human challenge contracts such as this that include a novel challenge agent manufacture and a challenge study.”