Open Orphan PLC (AIM:ORPH) hVIVO’s first ever Phase II field study site study awarded

First site study awarded offering new site services since facilities expansion

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 been awarded a new study with an existing Big Pharma client to act as a vaccination site for a Phase II field study of the client’s respiratory syncytial virus (RSV) vaccine candidate.

As part of the study, hVIVO will recruit 60 healthy volunteers to the Company’s new site clinic at Plumbers Row, where they will then be inoculated with either the RSV vaccine candidate or a placebo. As opposed to a human challenge study, where volunteers would then be challenged and quarantined within hVIVO’s FluCamp facilities, these participants will then be free to leave the facilities. Participants will then be monitored for RSV symptoms over the following months, with regular clinical check-ups at Plumbers Row, to assess the efficacy of the vaccine candidate and its ability to prevent illness through RSV. The study is expected to begin in Q3 2022 with the majority of revenue from the contract recognised in 2023.

This is the first vaccine field study the Company has been awarded since it announced the expansion of its facilities on 8 March 2022 . In addition to the core human challenge studies the expansion has enabled Open Orphan to provide a larger service offering including non-first in human Phase I trials such as PK (pharmacokinetics) studies, bridging studies and Phase II trials in patients and healthy volunteers.

The volunteers for the study will be recruited through the Company’s specialist volunteer recruitment arm, FluCamp . FluCamp has decades of experience attracting suitable healthy subjects to meet recruitment requirements, primarily sourcing subjects for hVIVO trials to date. FluCamp’s large database, tech-enabled platform and recently improved screening capabilities will mean that hVIVO is able to efficiently recruit and assess potential volunteers for its client’s field studies in a timely and cost-effective manner.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “This is a significant award for Open Orphan as it is our first study as a site. To date we have mainly acted as a Contract Research Organisation to provide either challenge studies, laboratory or consulting services. Although we have acted as a site as part of the challenge studies, we have not provided stand-alone site services. We expanded our facilities at Plumbers Row in March of this year with the aim to provide site services. It is a great testament to the team that they have been able to fulfil site activity work in such a short timeframe. There are a great number of synergies between our core challenge study activities and new the site services, this will help us to conduct the new work in an efficient manner.”

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, . 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 .

For further information please contact:

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

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