TIDMORPH
Open Orphan PLC
06 December 2021
6 December 2021
Open Orphan plc
("Open Orphan" or the "Company")
Positive results from Influenza Human Challenge Study conducted
by hVIVO
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 released from SAB
Biotherapeutics (NASDAQ: SABS) ("SAB"), reporting positive results
from a human challenge study testing SAB-176, its investigational
therapeutic for the treatment of seasonal influenza. hVIVO, a
subsidiary of Open Orphan, conducted the Phase 2a randomised,
double-blinded, placebo-controlled study using its Influenza Human
Challenge Study Model.
The trial evaluated the safety and treatment efficacy of SAB-176
in 60 healthy adults challenged with a pandemic influenza strain
(pH1N1). Participants were intranasally inoculated with the
influenza challenge virus and then randomised to receive either
SAB-176 or placebo.. SAB-176 achieved statistically significant (p
= 0.026) reductions in viral load. Based on partial data,
statistically significant reductions in clinical signs and symptoms
compared to placebo were also observed. Additionally, no serious
adverse events were reported and SAB-176 appeared to be safe and
well tolerated. Based on the positive results from this study, SAB
plans to further evaluate SAB-176 in a Phase 2 influenza clinical
trial.
Flu is caused by the influenza virus and is one of the most
common infectious respiratory diseases and can lead to severe
illness, and death. There are four types of seasonal influenza
viruses, types A, B, C and D. Influenza A and B viruses circulate
and cause seasonal epidemics of disease. According to the World
Health Organisation (WHO), worldwide, these annual epidemics are
estimated to result in about three to five million cases of severe
illness, and about 290 000 to 650 000 respiratory deaths.
hVIVO has two decades of experience and expertise in safely
conducting challenge studies across a range of respiratory and
infectious disease viruses, including respiratory syncytial virus
(RSV), Influenza, human Rhinovirus HRV (common cold virus),
malaria, and asthma. In October 2020, this expanded to include the
SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said : "I am
pleased that SAB has received positive results for SAB-176 from its
influenza human challenge trial, conducted by hVIVO. SAB-176 met
its primary endpoint and based on partial data appears to have met
a key secondary endpoint. These encouraging results support
proceeding to a Phase 2 clinical trial.
"Influenza affects a significant proportion of the global
population every year with symptoms ranging from mild to severe,
with hospitalisations and deaths occurring among high-risk groups.
hVIVO has successfully been delivering Influenza human challenge
trials for over two decades, and we look forward to continuing to
support Big Pharma and biotechs to provide early proof-of-concept
for novel vaccines and antivirals."
Mariya Kalinova, Medical Director, hVIVO, commented: "We are
delighted to see these positive results from the Phase 2a Influenza
Human Challenge Study for SAB Biotherapeutics' novel anti-influenza
human immunotherapy, SAB-176. The encouraging reductions in viral
load and clinical symptoms, along with the promising safety and
tolerability data observed in this challenge study suggest SAB-176
may have a positive impact on individuals with influenza.
"This successful study demonstrates the way that Phase 2a
challenge studies can help advance drug development and provide a
value inflection point for innovative products such as SAB-176 as
they move towards a full Phase 2 study. Moving forward, we expect
to see an increase in the number of human challenge studies taking
place across multiple infectious diseases, as interest in these
disease areas continues to grow."
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 & 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
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.
About SAB Biotherapeutics
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage,
biopharmaceutical company advancing a new class of immunotherapies
leveraging fully human polyclonal antibodies. SAB has applied
advanced genetic engineering and antibody science to develop
transchromosomic (Tc) Bovine(TM) that produce fully-human
antibodies targeted at specific diseases, including infectious
diseases such as COVID-19 and influenza, immune system disorders
including type 1 diabetes and organ transplantation, and cancer.
SAB's versatile DiversitAb(TM) platform is applicable to a wide
range of serious unmet needs in human diseases. It produces
natural, specifically targeted, high-potency, human polyclonal
immunotherapies. SAB is currently advancing multiple clinical
programs. For more information on SAB, visit:
https://www.sabbiotherapeutics.com/ and follow @SABBantibody on
Twitter.
About SAB-176
SAB-176 is a multivalent, broadly neutralizing fully-human
polyclonal antibody therapeutic candidate in development for the
treatment or prevention of severe influenza. The novel,
specifically-targeted therapeutic leverages the natural human
biological immune response to specifically bind to Type A and Type
B influenza viruses. Like vaccines, it can be modified to address
annual strain changes, when needed, to maintain broader coverage as
the flu virus mutates. Preclinical data suggests that SAB-176
offers broad protection against diverse influenza strains.
SAB's novel DiversitAb(TM) immunotherapy platform enables the
production of large amounts of targeted, highly potent human
polyclonal antibodies. The platform leverages transchromosomic
cattle (Tc Bovine(TM)) that have been genetically designed to
generate fully human antibodies (immunoglobulin G) rather than
bovine antibodies, in response to inoculation with an
immunogen.
To develop and produce SAB-176, Tc Bovine were hyperimmunized
with a quadrivalent antigen, including a number of influenza
strains. Within a brief period of time, the Tc Bovine generated
significant amounts of fully-human antibodies to combat the virus,
driving titers beyond the levels known to be protective. Plasma was
collected (in a similar manner as from human plasma donors), then
purified to isolate the antibodies that comprise the therapeutic
treatment.
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