TIDMORPH
RNS Number : 0005C
Open Orphan PLC
17 February 2022
Open Orphan plc
("Open Orphan" or the "Company")
Positive results from RSV Human Challenge Study
Data on Phase 2a study published in New England Journal of
Medicine
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, notes the announcement dated February 17 2022 from
Enanta Pharmaceuticals, Inc . (NASDAQ: ENTA), a clinical stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, on positive results from a
human challenge study assessing its respiratory syncytial virus
("RSV") antiviral candidate, EDP-938. The results from this human
challenge study have been published in The New England Journal of
Medicine. hVIVO , a subsidiary of Open Orphan, conducted the Phase
2a, double-blind, placebo-controlled trial using its RSV Human
Challenge Study Model.
The trial enrolled 178 healthy adult volunteers across two
parts, 18-55 years of age, who were intranasally challenged with
RSV-A Memphis 37b ("M37b"). Volunteers received either a dose of
EDP-938 or placebo for five days after infection, with different
dose levels of EDP-938 being assessed. The study demonstrated that
both viral load and clinical symptoms were significantly lower in
volunteers that received EDP-938 than those that received placebo,
with similar safety profiles between placebo and the antiviral
regimens. Importantly, no serious adverse events occurred.
RSV is a contagious, common respiratory virus that usually
causes mild, cold-like symptoms and 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.
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.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO said: "
It's pleasing to see another of our clients getting such positive
results from a human challenge study that we conducted, and that
the data has been published in The New England Journal of Medicine.
EDP-938 is a potentially important medicine that could help reduce
the global impact of RSV, and I look forward to following Enanta's
continued progression of the candidate through further clinical
trials."
Cathal Friel, Executive Chairman of Open Orphan, said : "We are
delighted to see that this important Phase 2a study of EDP-938 has
yielded such positive results. We are a world leader in testing
infectious and respiratory disease products using challenge studies
such as this, and RSV is just one portion of our portfolio of
challenge models, which also includes influenza, HRV, malaria,
asthma, and now SARS-CoV-2. We look forward to continue offering
our world class services to partners as we look to meet the growing
demand from the infectious disease market."
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
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
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing
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 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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