Shares of Open Orphan PLC (LON: ORPH) rose 7% after the company’s human challenge COVID-19 characterisation study received approval from a special clinical trials Research Ethics Committee (“REC”) to proceed.
Open Orphan is the first company in the world to design and execute a human challenge clinical trial aimed at reducing the number of participants needed to perform a clinical trial from thousands to a hundred or less.
The company, which provides clinical research services to other pharmaceutical companies, won a contract with the British government to develop a COVID-19 human challenge study model on October 20, 2020, leading to today’s announcement.
The characterisation study is currently enrolling participants and targets to innoculate up to 90 volunteers aged 18-30 years to identify the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment.
The study will be conducted by Open Orphan’s subsidiary, hVIVO at the Royal Free London NHS Foundation Trust's specialist clinical research unit, and sponsored by the Imperial College London.
In a media interview today, Open Orphan’s CEO, Cathal Friel, said that its valuation could surpass $1 billion soon given the huge interest that the challenge study has attracted from major pharmaceutical companies.
He also explained that the novel challenge studies could help determine the right dosages for COVID-19 vaccines and whether they are effective against any new disease variants.
Dr Andrew Catchpole, hVIVO’s Chief Scientific Officer, said: “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.”
Open Orphan share price.
Open Orphan shares edged 7.01% higher to trade at 30.5p, rising from Tuesday’s closing price of 28.5p.
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