Open Orphan plc

("Open Orphan" or the "Company")

£10.4m full-service contract signed with existing Big Pharma client

hVIVO to develop new influenza challenge strain to test oral antiviral candidate

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 £10.4m contract with an existing top 5 global pharmaceutical client to manufacture a new batch of H1N1 influenza challenge virus, leveraging off an existing in-house generated challenge model, and to conduct a human challenge trial to test the client's antiviral product.

hVIVO has world-leading expertise in challenge agent manufacture, with the ability to manufacture specific subtypes of viruses, as well as unrivalled experience in conducting challenge studies. Since the COVID-19 pandemic, the Company has seen an increase in the number of clients looking to test their vaccines and antivirals against specific subtypes of viruses that are circulating in the population or that have the potential to be widely spread. As a result, there is a greater interest in end-to-end human challenge contracts such as this, that include a novel challenge agent manufacture and a challenge study.

The study will evaluate the efficacy profile of the antiviral against the specific influenza subtype, generating data quickly and efficiently. This is the third human challenge contract signed with this client, highlighting the Company's world leading expertise and the clear benefits of human challenge trials to Big Pharma's drug development process. 

Good Manufacturing Practice ("GMP") compliant virus manufacturing activities will commence immediately and are expected to complete by Q2 2023. Once completed, hVIVO will conduct a Phase 2a double-blinded placebo-controlled human challenge study which is expected to be completed by Q4 2023. hVIVO will recruit healthy volunteers via the Company's dedicated volunteer recruitment arm, FluCamp. The majority of revenue from the contract is expected to be recognised during 2023.

Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said: "We're delighted to be working again with this top 5 global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team. This contract is the third challenge study with this client, and our second end-to-end full-service contract overall. Our one-stop shop service offerings from manufacturing bespoke challenge agents to conducting full challenge studies is unique in the market. I am confident, that with our highly qualified teams and their clinical development expertise, we are well placed to address the growing infectious disease and respiratory research markets.

"Influenza poses a serious global health threat, causing an estimated 290,000 - 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes. As illustrated with this contract, our world-class manufacturing capabilities can produce a challenge agent for subtypes that pose a particular global health risk or are already circulating in the population. The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies."

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.

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Notes to Editors

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.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre 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.

About Influenza (flu)

Influenza (flu) is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 - 650,000 deaths per year. Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza.

H1N1 is a subtype of the influenza A virus and have caused two pandemic outbreaks, including the 1918 Spanish flu and the 2009 swine flu pandemic.