ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

World's first Covid-19 human challenge study to expand

COVID-19 Human Challenge Programme update

hVIVO investigating COVID-19 infection in further volunteers on behalf of the UK Government

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces 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.

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." 

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."

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

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Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world's first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.