TIDMORPH
Open Orphan PLC
07 September 2021
7 September 2021
Open Orphan plc
("Open Orphan" or the "Company")
RSV Human Challenge Study conducted by hVIVO yields positive
results
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 , notes the announcement dated 1 September 2021
from Barvarian Nordic A/S (OMX: BAVA), reporting positive results
received from a human challenge study testing its respiratory
syncytial virus ("RSV") vaccine candidate, MVA-BN(R) RSV. hVIVO , a
subsidiary of Open Orphan, conducted the Phase 2 double-blinded,
placebo controlled trial using its RSV Human Challenge Study
Model.
The trial enrolled 61 healthy adult volunteers, 18-50 years of
age who were randomised to receive either a single vaccination of
MVA-BN RSV or placebo. Following this, volunteers were challenged
intranasally with an RSV type A strain 28 days. The study
demonstrated a significant reduction in viral load in vaccinated
subjects (n=30) versus placebo (n=31), thus meeting the primary
endpoint of this pivotal study. At the same time, the vaccinated
subjects showed a significant reduction in clinical symptoms
typically associated with RSV infections. The MVA-BN RSV vaccine
demonstrated a vaccine efficacy of up to 79% in preventing
symptomatic RSV infections. No vaccine-related serious adverse
events were observed, and the vaccine was well tolerated,
consistent with the safety profile previously reported in Phase 1
and Phase 2 clinical studies.
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 to at-risk older adults. Among the elderly (aged
65+), RSV causes as many hospitalisations and deaths as influenza
(source: CDC). 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 vaccine on the market for RSV.
hVIVO has two decades of experience and expertise in safely
conducting challenge studies across a range of respiratory and
infectious disease viruses, including various strains of influenza,
RSV, HRV, asthma and malaria, etc.
Cathal Friel, Executive Chairman, said: "We are delighted to see
the positive results emerge from this RSV Human Challenge Study
with Bavarian Nordic for its RSV vaccine candidate, which was run
by hVIVO. This Study illustrates the Company's diverse offering
across the infectious disease market.
"We are the only company in the world that is currently equipped
to run RSV challenge studies, which forms part of our wider
portfolio of respiratory and infectious disease challenge trials.
With the global infectious disease market expected to reach a value
of $250bn by 2025, we are already seeing a huge increase in
interest across the entire pharmaceutical and biotech space in
these previously underserved infectious disease areas. We look
forward to offering our industry leading services to help novel
therapeutics and vaccines progress through clinical
development."
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
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
/ Oscair McGrath
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)
Paul McManus/ Sam Allen/ Louis Ashe-Jepson +44 (0)7980 541 893/ +44 (0)
7502 558 258 / +44 (0) 7747
515393
Notes to Editors
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 with its highly specialised on-site
virology and immunology laboratory. Open Orphan has a leading
portfolio of human challenge study models for infectious and
respiratory diseases and is developing a number of other models
including the world's first COVID-19 human challenge study model as
part of the Human Challenge Programme.
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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September 07, 2021 02:00 ET (06:00 GMT)
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