Open Orphan PLC (LON:ORPH) shares rose on Wednesday as the company said the world’s first COVID-19 characterisation study received approval from a specially convened Research Ethics Committee (REC) following a contract received by the company’s subsidiary hVIVO from the UK government to develop a COVID-19 human challenge study model.
The pharmaceutical services and clinical research firm said the initial virus characterisation study will inoculate up to 90 volunteers between the ages of 18 and 30 years old to enable identification of the most appropriate dose of the virus needed to cause COVID-19 infection in a safe and controlled environment.
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Open Orphan added the study is set to commence shortly and will be conducted by hVIVO at the Royal Free London NHS Foundation Trust's specialist clinical research unit. The group said the virus being used in the 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.
"Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic”, hVIVO’s chief scientific officer Andrew Catchpole said in a statement.
"This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required.
Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection", he added.
Shares in Open Orphan were up 4.8% at 29.9p in early trading.