TIDMORPH
RNS Number : 9798F
Open Orphan PLC
25 March 2022
Open Orphan plc
("Open Orphan" or the "Company")
GBP5m RSV human challenge study contract win
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 GBP5m respiratory syncytial virus ("RSV")
human challenge study contract with a European biotechnology
company ("European biotech") to test its intravenous antiviral
candidate, using the hVIVO RSV Human Challenge Study Model.
The study is expected to commence this year and will test and
assess the efficacy of the client's antiviral candidate in a cohort
of healthy young adult volunteers. This contract builds on Open
Orphan's existing relationship with this European biotech,
following previous early clinical work completed by the Venn Breda
team, highlighting the Company's ability to maintain relationships
with its clients over time and to cross sell services between
brands. The Company expects the revenues from the contract to be
recognised across 2022 and 2023.
The study will be conducted by hVIVO's highly trained team of
medics at its state-of-the-art quarantine facilities in London
which was recently expanded in a cost-efficient manner from 43 to
62 beds, an increase of c. 45%. The Company's specialised virology
laboratories, hLAB, will provide qPCR (quantitative polymerase
chain reaction), infectivity and serology data for the study.
Healthy volunteers for the study will be recruited through the
Company's volunteer recruitment arm, FluCamp . The FluCamp
volunteer recruitment capacity was also recently expanded across
its screening facilities in London and Manchester to enable larger
cohorts to be recruited more quickly than before. The new screening
facilities opened in Manchester expands the Company's reach to
facilitate the increasing demand for human challenge studies and
allows the Company to recruit volunteers beyond the greater London
area.
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 up to 75,000 in-hospital
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.
hVIVO has a long history of challenge studies with its roots
dating back to 1947 with the establishment of the UK Common Cold
Clinic in Salisbury, which conducted some of the first influenza
human challenge studies. Since its establishment, the Company has
been conducting human challenge studies for a range of industry,
governmental and academic clients, and has the most frequently used
commercial challenge models on the market. hVIVO has expertise in
conducting challenge studies in its highly controlled clinical
environment, across a range of infectious and respiratory diseases,
including influenza, RSV, human rhinovirus (HRV - common cold
virus), malaria, SARS-CoV-2, asthma, COPD, and cough, and is
continuing to expand its offering.
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said :
"I am pleased to announce this GBP5m contract to test our client's
antiviral candidate using the hVIVO RSV Human Challenge Study
Model. RSV is a significant threat to public health, and we are
delighted to support this European biotech in the development of
its antiviral candidate.
"Following the recent expansion of our FluCamp facilities, which
boosts our volunteer and patient recruitment capabilities as well
as increasing our bed capacity by c.45%, we are now even better
equipped to identify volunteers and to complete our growing
pipeline of studies in a time efficient manner.
"Leveraging my extensive CRO experience, I look forward to
continuing to drive further contract wins across our portfolio of
infectious and respiratory disease challenge models."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said :
"This contract is a further demonstration of the significant value
of human challenge studies. Efficacy data provided by the Company
following the completion of the study can lead to entry into Phase
II as well as optimisation of a Phase III programme. For Big Pharma
as well as smaller biotechs, the substantial time and financial
savings compared to typical field-based studies is increasingly
making human challenge the trial design of choice for achieving
early proof of concept data."
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
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
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
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.
Open Orphan runs challenge studies in London from both its
19-bedroom Whitechapel quarantine clinic and its state-of-the-art
24-bedroom QMB clinic with its highly specialised on-site virology
and immunology laboratory. The Company has a leading portfolio of
human challenge study models for infectious and respiratory
diseases and is developing a number of new models. There has been
an explosion in the growth of the infectious disease market, which
is estimated to grow to in excess of $250bn by 2025. The Group is
focused on refreshing its existing challenge models and develop new
models, such as Malaria, to address the dramatic growth potential
of the global infectious disease market.
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. The
Disease in Motion platform has many potential applications across a
wide variety of end users including big technology, wearables,
pharma, and biotech companies.
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.
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