ORPH.L Regulatory News (ORPH)

26 March 2021

Open Orphan plc

("Open Orphan" or the "Company")

£7.5m Human Challenge Study Contract

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, has entered into a contract with a  biotechnology company to run a human viral challenge study for a respiratory syncytial virus ("RSV") prophylactic and treatment.

This US biotechnology company is developing a product for the prevention and treatment of acute and chronic respiratory syncytial virus infections. RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. There is currently no prophylactic or specific treatment on the market for RSV.

The total contract value is £7.5m and the study is due to commence in Q4 2021, with the majority of revenues being recognised in 2021. hVIVO will conduct this study on behalf of its client to demonstrate the efficacy of their lead candidate against RSV infection. The product is expected to have substantial advantages with respect to potency, safety, tolerability and convenience while fully maintaining efficacy when compared to other similar products.

Cathal Friel, Executive Chairman, said: "This is another substantial and significant contract win for hVIVO and Open Orphan. Through signing these deals, we continue to reinforce our position as the clear world leader in human challenge studies. Over the past year, Open Orphan has fully restructured, reorganised, and integrated our London, Paris and Breda operations to become a fast-growing, profitable provider of human challenge clinical trials in a manner required by the global pharmaceutical and biotechnology companies. We have expanded from one clinic to multiple clinics, and it is our stated objective to continue to invest and expand our global capability to ensure our position as the world leader in testing vaccines, antivirals, and monoclonal antibodies through the use of human challenge studies well into the future.

 With the ongoing expansion of our clinical footprint, we can now provide any pharmaceutical company, anywhere in the world, rapid access to challenge study clinical trials to gather data on their product in a relatively short time period. In the past, human challenge studies suffered from the perception that it was difficult to find a provider and that it may take a long period of time to complete, however, Open Orphan is transforming this view. We are delighted to see human challenge clinical trials now becoming an increasingly important part of pharmaceutical product testing and commercialisation.

hVIVO is currently the only company worldwide that can facilitate RSV challenge studies and we are in advance negotiations with all the significant RSV vaccine and drug developers globally. Our multiple state-of-the-art East London quarantine facilities are well equipped to carry out this study in a safe and controlled clinical environment."

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.

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 ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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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.