TIDMORPH
RNS Number : 7180O
Open Orphan PLC
14 June 2022
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF THE UK VERSION OF THE MARKET ABUSE REGULATION (EU)
NO.596/2014, WHICH FORMS PART OF UK LAW BY VIRTUE OF THE EUROPEAN
UNION (WITHDRAWAL) ACT 2018 ("UK MAR").
Open Orphan plc
("Open Orphan" or the "Company")
GBP7.2m RSV human challenge study contract
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 GBP7.2m contract with an existing top 5 global
pharmaceutical company to test its orally administered antiviral
product, using hVIVO's respiratory syncytial virus ("RSV") Human
Challenge Study Model.
The Phase 2a double-blinded placebo-controlled human challenge
study will take place at the Company's specialist quarantine
facilities in Whitechapel and will evaluate the safety and efficacy
profile of the antiviral against RSV. The study will commence in
June 2022, with the revenue being recognised in 2022 and 2023. As
part of the study, hVIVO will recruit healthy volunteers via the
Company's dedicated volunteer recruitment arm, FluCamp .
The client's antiviral is presently in Phase III clinical trials
for another infectious disease indication and the client will use
human challenge to assess the efficacy of their antiviral drug
candidate against RSV quickly and efficiently, highlighting the
value that human challenge studies can bring within the drug
development process. The repeat business from this top 5 global
pharmaceutical company underlines the Company's world leading
expertise and its ability to attract additional contracts from its
existing Big Pharma clients.
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said :
"We're delighted to be working with this top 5 global
pharmaceutical client again to test their antiviral candidate using
the hVIVO RSV Human Challenge Study Model. I am especially proud
that our world-class offering and customer service has secured
repeat business from another Big Pharma client, and that we are
seen as the 'go-to' partner for an increasing number of global drug
developers. The client's drug has already been shown to be an
effective antiviral in certain disease indications, and we're
pleased to now test its efficacy against RSV infection. RSV
continues to be a serious global health threat causing an estimated
100,000 annual deaths in children under the age of five ."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"This contract is a strong example of where human challenge studies
can provide significant value. With a drug that has existing safety
data and has been approved for one indication, human challenge
studies can provide fast, cost-effective efficacy data within a new
indication. The data will then indicate whether the candidate is
viable for a wider Phase II study, providing substantial time and
financial savings compared to traditional field-based studies."
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
Yamin 'Mo' 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 / +44 (0)7980 541 893 / +44 (0) 7502 558
Louis 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 4 million hospitalisations and an estimated 100,000
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.
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