Open Orphan plc (LON:ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, has announced that hVIVO, a subsidiary of Open Orphan plc, is continuing to work with the UK Government to inoculate up to 20 further volunteers as part of the world’s first COVID-19 characterisation study.
As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers. The UK Government has decided to expand the Human Challenge Programme to answer further questions that can help in the fight against COVID-19.
The study expansion will commence as soon as appropriate regulatory approvals and clinical preparations are complete. The study is funded by the UK Government who have commissioned Imperial College London to act as the clinical study sponsor. The study is conducted by hVIVO at the Royal Free Hospital, under the supervision of our highly trained scientists and medics.
The virus being used in the characterisation study has been produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.
The data from this study is already providing valuable insight into the biology of the virus which causes COVID-19. This knowledge will improve the ability to manage the virus and deliver a range of treatment options in the future.
The revenue from the contract is expected to be recognised in the current financial year.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are delighted to announce this study expansion with the UK Government. This will enable 20 further volunteers to participate in this next phase of the world’s first study of its kind which will help scientists better understand and treat COVID-19.
“Open Orphan, through its subsidiary hVIVO, is proud to be working with the UK Government’s Human Challenge Programme in this initiative to help control and minimise the spread of the virus and we will look to provide updates on the study with further announcements in due course.”
Caroline Clarke, Royal Free London group chief executive, said: “We are excited to enter this next phase of this study with our partners from hVIVO, Imperial College London and the government’s Vaccine Taskforce. Ultimately, we hope this research will give us more information about vaccines, as well as its impact on infection rates, and enable us to provide better treatments in the future for patients with COVID-19.”
Cathal Friel, Executive Chairman of Open Orphan, said: “At Open Orphan we are committed to helping the UK Government in partnership with two great institutions, Imperial College London and the Royal Free Hospital, to discover effective treatments for COVID-19. This study expansion further illustrates the effectiveness and importance of this study.”