ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

£5m RSV human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £5m respiratory syncytial virus ("RSV") human challenge study contract with a European biotechnology company ("European biotech") to test its intravenous antiviral candidate, using the hVIVO RSV Human Challenge Study Model.

The study is expected to commence this year and will test and assess the efficacy of the client's antiviral candidate in a cohort of healthy young adult volunteers. This contract builds on Open Orphan's existing relationship with this European biotech, following previous early clinical work completed by the Venn Breda team, highlighting the Company's ability to maintain relationships with its clients over time and to cross sell services between brands. The Company expects the revenues from the contract to be recognised across 2022 and 2023.

The study will be conducted by hVIVO's highly trained team of medics at its state-of-the-art quarantine facilities in London which was recently expanded in a cost-efficient manner from 43 to 62 beds, an increase of c. 45%. The Company's specialised virology laboratories, hLAB, will provide qPCR (quantitative polymerase chain reaction), infectivity and serology data for the study. 

Healthy volunteers for the study will be recruited through the Company's volunteer recruitment arm, FluCamp. The FluCamp volunteer recruitment capacity was also recently expanded across its screening facilities in London and Manchester to enable larger cohorts to be recruited more quickly than before. The new screening facilities opened in Manchester expands the Company's reach to facilitate the increasing demand for human challenge studies and allows the Company to recruit volunteers beyond the greater London area.

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and up to 75,000 in-hospital deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.

hVIVO has a long history of challenge studies with its roots dating back to 1947 with the establishment of the UK Common Cold Clinic in Salisbury, which conducted some of the first influenza human challenge studies. Since its establishment, the Company has been conducting human challenge studies for a range of industry, governmental and academic clients, and has the most frequently used commercial challenge models on the market. hVIVO has expertise in conducting challenge studies in its highly controlled clinical environment, across a range of infectious and respiratory diseases, including influenza, RSV, human rhinovirus (HRV - common cold virus), malaria, SARS-CoV-2, asthma, COPD, and cough, and is continuing to expand its offering.

Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said: "I am pleased to announce this £5m contract to test our client's antiviral candidate using the hVIVO RSV Human Challenge Study Model. RSV is a significant threat to public health, and we are delighted to support this European biotech in the development of its antiviral candidate.

"Following the recent expansion of our FluCamp facilities, which boosts our volunteer and patient recruitment capabilities as well as increasing our bed capacity by c.45%, we are now even better equipped to identify volunteers and to complete our growing pipeline of studies in a time efficient manner.

"Leveraging my extensive CRO experience, I look forward to continuing to drive further contract wins across our portfolio of infectious and respiratory disease challenge models."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "This contract is a further demonstration of the significant value of human challenge studies. Efficacy data provided by the Company following the completion of the study can lead to entry into Phase II as well as optimisation of a Phase III programme. For Big Pharma as well as smaller biotechs, the substantial time and financial savings compared to typical field-based studies is increasingly making human challenge the trial design of choice for achieving early proof of concept data."

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 contract research company that is a world leader in testing infectious and respiratory disease products 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 and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been an explosion in the growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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.

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.