Open Orphan PLC Successful completion of toxicology study
23 Décembre 2020 - 8:00AM
RNS Non-Regulatory
TIDMORPH
Open Orphan PLC
23 December 2020
REACH
23 December 2020
Open Orphan plc
("Open Orphan" or the "Company")
Successful completion of PrEP Biopharm Toxicology study for
respiratory 'viral mimic'
Phase IIb study to validate efficacy of PrEP-001 against
circulating respiratory viruses such as COVID-19, flu and the
common cold
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services CRO which is the world leader in the
testing of vaccines and antivirals using human challenge clinical
trials, announces that drug development company PrEP Biopharm
Limited ("PrEP Biopharm"), which is 62.6% owned by Open Orphan, has
successfully completed a 12-week toxicology study for its novel
pan-viral prophylactic asset, PrEP-001.
The animal model study provides safety data needed to move
PrEP-001 into longer duration dosing in clinical studies. PrEP
Biopharm intends to move forward with a real-world, field trial
intended to validate the efficacy of its PrEP-001 against all
circulating respiratory viruses, including COVID-19, influenza and
the common cold.
PrEP-001 is neither a vaccine nor an antiviral. Rather, it is a
synthetic RNA 'viral mimic' that stimulates the body's pan-viral
innate immune response locally in the upper respiratory tract.
Administered via a once daily nasal spray it leverages the innate
immune system to create an antiviral environment to stop invading
respiratory viruses. As such, it is possible that PrEP-001 could be
used as a stand-alone pan-viral prophylaxis or as an adjuvant for
live and inactivated or peptide intranasal vaccines targeting
specific respiratory viruses. Previous studies in animals have
demonstrated that intranasal administration of poly IC shortly
after vaccination with live attenuated, inactivated and
haemagglutinin antigen preparations of influenza virus enhanced
respiratory dendritic cell function, CD8 T cell formation, and
production of neutralising antibodies.
When Open Orphan acquired hVIVO in January 2020, in addition to
acquiring the world leader in the testing of vaccines and
antivirals using human challenge studies, hVIVO also came with a
number of non-core assets including a 62.6% stake in PrEP Biopharm.
The previous hVIVO Board had used shareholders' funds to invest in
these non-core assets. The Open Orphan Board and management team
are primarily focussed upon cementing its position as a unique CRO
and is committed to directing all resources to further improving
the quality of earnings in both Venn Life Sciences and hVIVO and
with shareholder funds only being used to support the profitable
CRO services business. In recent months, Open Orphan has made it
clear that it intends to monetise these non-core assets, however,
as part of monetising these non-core assets, Open Orphan does not
intend to invest any of the Open Orphan shareholders' funds but
will continue to work with the PrEP Biopharm management team to
secure other sources of funding outside of the Open Orphan group
while maximising the potential of these non-core assets.
Cathal Friel, Executive Chairman of Open Orphan, said: "It is
very encouraging to note PrEP Biopharm's progress towards the
ultimate goal of validating the effectiveness of their one dosage
nasal spray for key respiratory viruses like COVID-19, flu and the
common cold. This safety data allows them to move into Phase 2b
field studies and we are very excited that PrEP-001 could play a
meaningful role in the current COVID-19 pandemic and future
potential pandemics caused by new respiratory viruses."
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 & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
+44 (0)7876 741 001 / +44 (0)7980
Anna Dunphy / Paul McManus 541 893
About Open Orphan ( www.openorphan.com )
Open Orphan is a rapidly growing niche CRO pharmaceutical
services company which is a world leader in the testing of vaccines
and antivirals through the use of human challenge clinical trials.
Conducted from Europe's only 24-bedroom quarantine clinic with
onsite virology providing individually isolated rooms and connected
to our specialist laboratory facility. hVIVO's challenge studies
require healthy volunteers to take part, volunteers are recruited
through FluCamp, learn more at www.FluCamp.com . The hVIVO facility
offers highly specialised virology and immunology laboratory
services to support pre-clinical and clinical respiratory drug,
antiviral, and vaccine discovery and development. Reliable
laboratory analysis underpinned by scientific expertise is
essential when processing and analysing clinical samples. Robust
quality processes support our team of scientists in the delivery of
submission ready data.
The Company has a leading portfolio of 8 viral challenge study
models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD
viral challenge models. As announced in early March, Open Orphan is
rapidly advancing a number of Coronavirus challenge study models
and expects to be helping many COVID-19 vaccine development
companies to test their vaccines. No other company in the world has
such a portfolio, with only two competitors globally having 1
challenge study model each. hVIVO also works with companies in the
UK and Ireland to provide COVID-19 testing to staff to protect
staff and customers from a workplace COVID-19 outbreak through its
COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services
businesses, hVIVO and Venn Life Sciences and is also building out a
valuable data platform business. hVIVO has built up one of the
world's largest databases of infectious disease progression data
and we are populating our Open Orphan Health Data platform with
this historical hVIVO data. In our clinical trials going forward,
we are also planning to collect data on volunteer's via wearables
during clinical trials. Therefore, Open Orphan's data, which may
yield valuable digital biomarkers, could be one of the more
sought-after datasets by many of the large wearables /smart watch
wearables providers around the world. In June 2019, Open Orphan
acquired AIM-listed Venn Life Sciences Holdings plc in a reverse
take-over and in January 2020 it completed the merger with hVIVO
plc in January 2020. Venn is an integrated drug development
consultancy firm which offers CMC (chemistry, manufacturing and
controls), preclinical, Phase I & II clinical trials design and
execution. The merger with hVIVO created a European full pharma
services company broadening the Company's customer base and with
complementary specialist CRO services, widened the range of the
Company's service offerings.
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