TIDMORPH
RNS Number : 5651T
Open Orphan PLC
26 March 2021
26 March 2021
Open Orphan plc
("Open Orphan" or the "Company")
GBP7.5m Human Challenge Study Contract
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services clinical research organisation (CRO) and
world leader in vaccine and antiviral testing using human challenge
clinical trials , announces that hVIVO , a subsidiary of Open
Orphan, has entered into a contract with a biotechnology company to
run a human viral challenge study for a r espiratory syncytial
virus ("RSV") prophylactic and treatment.
This US biotechnology company is developing a product for the
prevention and treatment of acute and chronic r espiratory
syncytial virus infections. RSV is a contagious virus that affects
the respiratory tract of children and at-risk older adults; in
severe cases, it can cause pneumonia and other life-threatening
breathing difficulties. RSV is a significant public health threat
and is one of the leading causes of hospitalisation of young
children across the world. It also poses a significant threat to
at-risk older adults; in the current climate, RSV may also lower
immunity and increase the risk of developing COVID-19, and where
these infections occur together, it can worsen the severity of
COVID-19 illness. There is currently no prophylactic or specific
treatment on the market for RSV.
The total contract value is GBP7.5m and the study is due to
commence in Q4 2021, with the majority of revenues being recognised
in 2021. hVIVO will conduct this study on behalf of its client to
demonstrate the efficacy of their lead candidate against RSV
infection. The product is expected to have substantial advantages
with respect to potency, safety, tolerability and convenience while
fully maintaining efficacy when compared to other similar
products.
Cathal Friel, Executive Chairman, said: "This is another
substantial and significant contract win for hVIVO and Open Orphan.
Through signing these deals, we continue to reinforce our position
as the clear world leader in human challenge studies. Over the past
year, Open Orphan has fully restructured, reorganised, and
integrated our London, Paris and Breda operations to become a
fast-growing, profitable provider of human challenge clinical
trials in a manner required by the global pharmaceutical and
biotechnology companies. We have expanded from one clinic to
multiple clinics, and it is our stated objective to continue to
invest and expand our global capability to ensure our position as
the world leader in testing vaccines, antivirals, and monoclonal
antibodies through the use of human challenge studies well into the
future.
With the ongoing expansion of our clinical footprint, we can now
provide any pharmaceutical company, anywhere in the world, rapid
access to challenge study clinical trials to gather data on their
product in a relatively short time period. In the past, human
challenge studies suffered from the perception that it was
difficult to find a provider and that it may take a long period of
time to complete, however, Open Orphan is transforming this view.
We are delighted to see human challenge clinical trials now
becoming an increasingly important part of pharmaceutical product
testing and commercialisation.
hVIVO is currently the only company worldwide that can
facilitate RSV challenge studies and we are in advance negotiations
with all the significant RSV vaccine and drug developers globally.
Our multiple state-of-the-art East London quarantine facilities are
well equipped to carry out this study in a safe and controlled
clinical environment."
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
.
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 ("MAR"). With the
publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the
public domain.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
/ Dan Gee-Summons
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 +44 (0)20 7933 8780 or openorphan@walbrookpr.com
& IR)
Anna Dunphy / Paul McManus +44 (0)7876 741 001 / +44
(0)7980 541 893
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing
pharmaceutical service/contract research company that is a world
leader in testing vaccines and antivirals 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, opened in February 2021,
and its 24-bedroom QMB clinic which also has a highly specialised
virology and immunology laboratory on-site. Open Orphan has a
leading portfolio of eight human challenge study models for
conditions such as RSV, flu, asthma and COPD. In addition, Open
Orphan is also developing the world's first COVID-19 human
challenge study model as part of the Human Challenge Programme and
has signed a reservation contract with the UK Government for the
first three COVID-19 vaccine challenge 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. The
Disease in Motion platform has many potential applications across a
wide variety of end users including big technology, wearables,
pharma and biotech companies. Following COVID-19 there is now a
renewed interest and investment in infectious diseases.
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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