TIDMHVO
RNS Number : 6819M
hVIVO plc
10 January 2019
hVIVO plc
("hVIVO" or the "Company")
HVIVO reports that the Phase IIb viral challenge Study for FLU-v
(FLU-v004) achieved the primary endpoint of a statistically
significant reduction in Mild to Moderate Influenza
Update to results announced 26 March 2018
Completes a compelling Phase II FLU-v data package around this
first-in-class 'universal', broad spectrum, standalone, influenza
vaccine candidate
- Primary endpoint achieved
- Additional endpoint achieved statistical significance and is
identified as potential primary endpoint for future Phase III
trials
London, UK 10 January 2019: hVIVO plc (AIM: HVO), an industry
leading clinical development services business pioneering human
disease models based upon viral and allergen challenge, today
announces positive result for the primary endpoint, following
completion of analysis of samples by NIAID and additional results
from the Phase IIb viral challenge study of FLU-v, (Study 004,
NCT03180801). FLU-v is being developed by Imutex Limited, hVIVO's
49% joint venture with the SEEK Group.
-- Following additional analysis of the samples from the study
by the National Institute of Allergy and Infectious Diseases
(NIAID), part of the U.S. National Institutes of Health, hVIVO
reports that the study's primary endpoint achieved a statistically
significant result
o One dose of FLU-v produced a highly statistically significant
reduction in the primary endpoint of Mild to Moderate Influenza
Disease (MMID), comprising a positive signal of influenza infection
and at least one influenza symptom, compared with placebo
(p=0.035)
-- A statistically significant additional endpoint has been
achieved (p=0.006) from further data analysed by the NIAID from
FLU-v 004, which confirmed the result for the primary endpoint and
has the potential to become the primary regulatory endpoint for
Phase III
-- These results together with the previously reported highly
statistically significant reduction in symptoms endpoint (p=0.023)
and performing better than placebo in a number of other key
endpoints is evidence of the vaccine's protective effect
Trevor Phillips, Executive Chairman of hVIVO, said: "We are
pleased to finally be in a position to report a positive primary
endpoint outcome for this Phase IIb challenge study resulting from
the NIAID's additional analysis of samples taken during the study.
These results follow an announcement in March 2018 confirming that
key secondary endpoints in symptom reduction had achieved
statistical significance and indicating that the NIAID would be
conducting further sample analyses to assess the primary endpoint
outcome, as the initial analysis, using results from a less
sensitive assay for the presence of influenza virus, had showed the
primary endpoint only trended to statistical significance. The more
sensitive assay, routinely utilised by NIAID to assess the presence
of virus, identified more cases of influenza infection than had
originally been determined, resulting in the achievement of
statistical significance. These final results are further
verification that FLU-v is achieving measures of clinical efficacy
and is now positioned to enter Phase III. The successful
achievement of statistical significance in the primary endpoints
from two Phase II studies confirms that FLU-v has clinical impact
in establishing immunity and disease, symptom and viral load
reduction. The exploratory design of -004 has also enabled us to
determine, what we believe to be the most appropriate clinical
efficacy endpoint, relating to confirmed influenza infection, for
application in the Phase III programme and we look forward to
discussing this with the regulatory authorities at our next
meetings.
We continue to endeavour to progress strategic discussions with
regards to our joint venture, Imutex, and to maximise the strategic
options available to both companies as we now await publication of
the data from the UNISEC and NIAID FLU-v studies in peer reviewed
journals."
Gregory Stoloff, Chief Executive Officer of SEEK, said: "NIAID
has been conducting further and a more sensitive viral detection
analysis on the FLU-v challenge study results as previously
communicated. Our FLU-v vaccine has now demonstrated in two
different Phase IIb studies, a statistically enhanced immune
response which has translated into a statistical reduction in the
number of people getting sick and severity of influenza symptoms
which remains a significant burden to public health globally."
Further details on Phase IIb challenge study of FLU-v (FLU-v
004)
A challenge study conducted by hVIVO using the NIAID virus,
methods and analysis as a result of a collaboration between SEEK
and NIAID.
A randomised, double-blind, placebo-controlled single-centre
trial in collaboration with to assess the efficacy and safety of
two different formulation and dosing regimens of FLU-v vaccine
administered in healthy adults. In this trial, 123 subjects (aged
18-60 years) were assigned to either placebo or treatment arms.
-- The primary endpoint was to assess the incidence of MMID
which is defined as evidence of viral shedding in nasopharyngeal
swab samples and the presence of at least one symptom.
Supportive regulatory and academic environment
The development of a universal influenza vaccine has become a
worldwide public health priority in both industrialised and low-and
middle-income countries. A large number of government, academic,
public and private organisations (such as, for example, WHO, BARDA,
NIH, FDA and EMA) are supportive of development of such a vaccine.
These global stakeholders have indicated the benefits of vaccines
that induce broad immunity so as to prime the population against
newly emerging influenza viruses or other respiratory viruses of
pandemic potential.
Significant unmet need
FLU-v is intended to address a number of key issues associated
with current annual influenza vaccines whose effectiveness varies
from year to year, which need to be redesigned every year, are
available in limited quantities due to manufacturing cost,
complexity and lead times and which offer limited protection over
pandemic influenza. A synthetic universal flu vaccine offering long
lasting protection across a broad spectrum of influenza which could
be given to a much broader population would be a significant step
forward, and a potential future blockbuster in terms of sales.
- Ends -
For further information please contact:
hVIVO plc +44 207 756 1300
Trevor Phillips (Executive Chairman)
Fleur Wood (EVP, Investor Relations & Communications)
Numis Securities Limited +44 207 260 1000
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black / Michael Burke (Corporate Broking)
FTI Consulting +44 203 727 1000
Simon Conway / Victoria Foster Mitchell
This announcement is released by hVIVO plc and contains inside
information for the purposes of the Market Abuse Regulation (EU)
596/2014 ("MAR") and is disclosed in accordance with the Company's
obligations under Article 17 of MAR. The person who arranged for
the release of this announcement on behalf of hVIVO plc was Trevor
Phillips, Executive Chairman.
Notes to Editors:
About FLU-v - a Phase III enabled, broad spectrum stand-alone,
universal influenza vaccine candidate
FLU-v is a novel first-in-class, broad spectrum, true
stand-alone, influenza vaccine candidate. FLU-v is designed to
provide broad spectrum cover against multiple influenza strains and
does not require annual immunisation alongside an annual influenza
vaccine to confer immunity. It is also designed to minimise the
impact of the influenza virus by reducing symptoms, potentially
relegating influenza to a much milder disease by stimulating an
immune response mediated through T-cells and B-cells to the
internal proteins, in contrast to seasonal influenza vaccines that
prevent infection through antibody protection against external
proteins. In 2017, there were two FLU-v Phase IIb studies
conducted- 003 (field study) and 004 (human viral challenge
study).
FLU-v is a synthetic polypeptide vaccine which means that it is
not reliant on traditional manufacturing techniques with inherent
risks, in particular the potential of a miss-match of virus
particularly relevant for a pandemic strain. FLU-v is designed to
protect against a broad range of influenza viral strains and this
includes unexpected seasonal strains or a potentially devastating
pandemic strain.
FLU-v is being developed by Imutex Limited, hVIVO's 49% joint
venture with PepTcell Limited, trading as the SEEK Group
("SEEK").
About Influenza
Influenza is one of the major person-to-person transmittable
respiratory viral infections in humans. Globally, seasonal
influenza epidemics cause 3 million hospitalisations and 290,000 -
650,000 deaths annually(1) . The annual global economic burden
associated with seasonal influenza globally is $260 billion and the
impact of a severe pandemic can result in millions of deaths, and
even the most conservative estimates suggest that pandemics destroy
up to 1% of the global GDP(2) . The current strategy to prevent
influenza-associated health risks is annual immunisation of risk
populations. Yet, current vaccines need to be adjusted each year
and even then it is not guaranteed that they will match the
circulating epidemic virus. Moreover, current vaccines are not
effective against newly emerging influenza virus strains as
demonstrated during the H1N1 influenza pandemic in 2009. Universal
influenza vaccines which would be capable of providing protection
against a broad spectrum of influenza virus strains are thus
urgently needed. Such vaccines need to be based on conserved
constituents of the virus and should raise humoral as well as
cellular immunity that effectively protect against
influenza-associated disease symptoms.
About hVIVO:
hVIVO plc ("hVIVO") is pioneering a human-based clinical trial
platform to accelerate drug and vaccine development in respiratory
and infectious diseases. Leveraging human disease models in flu,
RSV, HRV and respiratory indications, the hVIVO platform captures
disease in motion, illuminating the entire disease life cycle from
healthy to sick and back to health. Based in the UK, market leader
hVIVO has conducted more than 50 clinical studies and inoculated
over 2500 volunteers.
About SEEK Group (PepTCell Limited, trading as SEEK Group)
SEEK's strategy is to bring safe, effective and low-cost
medicines to patients as quickly as possible, to radically improve
human health in major disease areas.
We do this by:
-- Modifying existing medicines to improve their efficacy
-- Using existing medicines in new indications
-- Creating new chemical entities
Working in these different ways allows us to optimise the
regulatory approval pathway to ensure that we bring safe and
effective products to patients in the shortest possible time.
Forward-looking statements
This announcement includes statements that are, or may be deemed
to be, forward-looking statements. These forward-looking statements
can be identified by the use of forward-looking terminology,
including the terms anticipates, believes, estimates, expects,
intends, may, plans, projects, should or will, or, in each case,
their negative or other variations or comparable terminology, or by
discussions of strategy, plans, objectives, goals, future events or
intentions. These forward-looking statements include all matters
that are not historical facts. Any forward-looking statements in
this announcement reflect the Group's (or, as the case may be, the
hVIVO directors') current view with respect to future events and
are subject to risks relating to future events and other risks,
uncertainties and assumptions relating to the Group's operations,
results of operations and growth strategy. Investors should
specifically consider the factors identified in this announcement
which could cause actual results to differ before making an
investment decision.
(1) http://www.endfluenza.com
(2) CDC, WHO
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END
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