Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company, which is the world leader in the testing of vaccines and antivirals using human challenge studies, is pleased to announce the signing of a contract by hVIVO, a subsidiary of Open Orphan, with the UK Government to develop a COVID-19 (SARS-CoV-2) human challenge study model.
The model development involves the manufacture of the challenge virus and the first-in-human characterisation study for this virus. The characterisation study, which is expected to complete in May 2021 and will require regulatory and ethical approval, enables identification of the most appropriate dose of the challenge virus for use in future human challenge studies, which play a vital role in helping to develop vaccines and antivirals for infectious diseases such as COVID-19.
The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics. hVIVO will also be expanding its Clinical Operations in London to facilitate work at this site.