TIDMORPH
RNS Number : 3776K
Open Orphan PLC
05 May 2022
Open Orphan plc
("Open Orphan" or the "Company")
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, 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
.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Yamin Khan, Chief Executive Officer
Liberum Capital (Nominated Adviser
and Joint Broker) +44 (0) 20 3100 2000
Ben Cryer/ Edward Mansfield/ Phil
Walker/ Will King
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard
Chambers
Davy (Euronext Growth Adviser and
Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Sam Allen / Louis +44 (0)7980 541 893 / +44 (0) 7502 558
Ashe-Jepson 258 /
+44 (0) 7747 515393
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(R) platform, this unique dataset includes clinical,
immunological, virological, and digital (wearable) biomarkers.
About RSV
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 four million hospitalisations and up to 75,000
in-hospital deaths in children under the age of five 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.
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