TIDMORPH
Open Orphan PLC
22 February 2022
Reach
22 February 2022
Open Orphan plc
("Open Orphan" or the "Company")
FDA Breakthrough Designation for Big Pharma RSV candidate
Vaccine candidate assessed in successful human challenge trial
conducted by hVIVO
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 14 February 2022 from
Bavarian Nordic A/S ("Bavarian Nordic") (OMX: BAVA), reporting that
the US Food and Drug Administration ("FDA") has granted
Breakthrough Therapy Designation for Bavarian Nordic's respiratory
syncytial virus ("RSV") vaccine candidate, MVA-BN(R) RSV. hVIVO , a
subsidiary of Open Orphan, successfully conducted a Phase 2,
double-blinded, placebo controlled human challenge trial to assess
MVA-BN(R) RSV using its RSV Human Challenge Study Model.
A Breakthrough Therapy Designation is designed to expedite the
development and regulatory review of medicines that are intended to
treat a serious condition. The designation has been granted upon
the assessment of preliminary clinical evidence for MVA-BN RSV,
indicating that the vaccine candidate may demonstrate substantial
improvement over available therapy on a clinically significant
endpoint. A significant portion of this preliminary evidence was
the successful challenge study conducted by hVIVO. The designation
provides an option to work more closely with FDA for the
development and review of MVA-BN RSV.
The challenge study conducted by hVIVO to assess MVA-BN(R) RSV
demonstrated a significant reduction in viral load in vaccinated
subjects versus placebo, thus meeting the primary endpoint of the
study. At the same time, 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, 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 infectious and
respiratory disease areas, including various strains of influenza,
RSV, HRV, COVID-19, asthma and malaria, etc.
Cathal Friel, Executive Chairman, Open Orphan plc, said: "We are
pleased to see Bavarian Nordic achieve Breakthrough Therapy
Designation for its RSV vaccine candidate, MVA-BN(R) RSV. hVIVO
successfully conducted a human challenge trial on behalf of
Bavarian Nordic in 2021, where the candidate showed a significant
reduction in clinical symptoms associated with RSV.
"The data from this human challenge trial was part of the body
of evidence provided by Bavarian Nordic to the FDA in order to
secure its Breakthrough Therapy Designation, which could ultimately
result in an expedited regulatory review of MVA-BN(R) RSV. This
highlights a major benefit of human challenge trials, in that they
enable drug developers to obtain Phase 2/2a efficacy data for their
vaccine and antivirals candidates in a fast, cost-effective manner
ahead of larger scale studies. This data can then strengthen
submissions for important regulatory programmes such as the
Breakthrough Therapy Designation."
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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