TIDMHVO
RNS Number : 3988W
hVIVO plc
09 February 2017
For immediate release 7.00am: 9 February 2017
HVIVO PLC
("hVIVO" or the "Company")
hVIVO announces data from two Phase IIa clinical studies to
further profile
PrEP Biopharm's PrEP-001 as a potential prophylactic against the
common cold
hVIVO plc (AIM: HVO), a specialty biopharma company with
discovery and clinical testing capabilities, announces data from
two exploratory Phase IIa studies of PrEP Biopharm's PrEP-001 as a
prophylactic against the human rhinovirus 16 (HRV-16), a pathogen
associated with the common cold. hVIVO holds a significant equity
stake in PrEP Biopharm Limited, a UK biotech company developing
drugs to treat respiratory infectious disease. PrEP-001 is a novel,
nasally administered, broad-spectrum agent designed to leverage the
body's innate immune system to prevent respiratory tract viral
infections. Following the previously reported positive proof of
concept studies in healthy volunteers challenged with influenza
(2016)(1) and HRV-16 (2014), these additional Phase IIa studies
were designed to further profile PrEP-001 in a specific patient
population, namely people with asthma, and to explore optimal
dosing schedules.
Highlights
Study PrEP-CS-002
-- Double-blind, randomised, placebo controlled study, conducted
in 40 patients with mild-moderate controlled asthma challenged with
HRV-16
-- The primary endpoint was a patient assessed Total Symptom
Score (TSS)(2) , and a statistically significant difference
compared to placebo was not met in the intent to treat (ITT)
population
-- However, there was a statistically higher number of patients
who had no symptoms (zero TSS) in the active group (5/19, 26.3%)
compared to the placebo group (0/20, 0%) (Fisher Exact Test,
p=0.002), suggesting a strong responder subgroup was present(3)
-- In addition, analysis of a modified ITT, which excluded two
significant outliers, showed that the TSS peak was significantly
lower in the active compared to the placebo group (p=0.031)
-- Further analysis of this subset of responders to fully
characterise the observed results will be undertaken to determine
next steps
-- PrEP-001 was well tolerated - The adverse event profile was
similar in active and placebo arms and was consistent with previous
studies with the drug
-- Further development plans for the drug to be communicated later in the year
Study PrEP-CS-003
-- Double-blind, randomised, placebo-controlled study, conducted
in 96 healthy subjects challenged with HRV-16, exploring the impact
of two potential dosing schedules for PrEP-001 on the duration of
the prophylactic effect
o PrEP-001 was dosed either seven and six days prior to viral
inoculation or four and three days before inoculation using the
dose of 6400 mcg
-- The primary endpoint was the difference in patient assessed
TSS - There was no statistically significant difference between the
two dosing schedules and placebo, suggesting once daily dosing may
be a more appropriate dosing regimen
-- PrEP-001 was well tolerated - The adverse event profile was
similar in active and placebo arms and was consistent with previous
studies with the drug
Kym Denny, CEO of hVIVO, commented;
"While PrEP-CS-002 and PrEP-CS-003 did not meet their primary
endpoints, these exploratory studies provide valuable insights for
PrEP-001 and build on the profile of the drug following the
previously reported positive proof of concept trials in flu and the
common cold. We are encouraged by signs of a potential treatment
effect in the asthma responder subgroup for this complex
respiratory disease where multiple phenotypes are recognised but
not fully understood. PrEP Biopharm will now undertake further
clinical characterisation of the results to inform the Company's
future development of PrEP-001. I look forward to updating the
market on future plans later in the year."
Further details on the study design
PrEP-CS-002: A Phase IIa, Double-Blinded, Randomised, Controlled
Study to Examine the Prophylactic Efficacy, Safety and Tolerability
of PrEP-001 in Asthmatic Subjects Subsequently Challenged with
Human Rhinovirus (HRV-16)
This study was conducted in subjects with GINA(4) 1 to 3
controlled asthma challenged with HRV-16. It was designed as a
two-part study, consisting of a viral challenge arm and a safety
arm. The viral challenge arm consisted of a double-blind placebo
controlled study (N=19 active, N=20 placebo) with two days of
dosing followed by viral challenge. Individuals were then
quarantined for 8 days post-inoculation. Symptoms were
self-assessed through diary cards consisting of a total of 10 upper
and lower respiratory and systemic symptoms, using a 4-point scale
for severity assessment. The safety arm consisted of two arms with
two doses, (6400 and 12800 mcg; N=20); in the first arm 6 subjects
received 6400 mcg and 4 placebo and in the second arm 6 received
12800 mcg and 4 placebo.
The primary objective of the trial was to assess the
prophylactic effect of repeated intranasal dosing with PrEP-001 in
subjects with asthma subsequently challenged with HRV-16 on the
changes in clinical symptoms following HRV infection, when compared
to placebo. The primary endpoint was the difference in the "area
under the curve" of TSS, post viral challenge, between the
treatment arm and the placebo arm. Secondary endpoints included
symptom severity, peak and duration of symptoms, viral
load/shedding (qPCR), rates of infectivity, seroconversion and lab
confirmed HRV-illness, change in peak expiratory flow (PEF), nasal
discharge weight and AE profile. Exploratory end points included
evaluation of various blood and nasal lining fluid biomarkers,
which will be reported at a future date.
PrEP-CS-003: A Phase IIa, Randomised, Double-Blind,
Placebo-Controlled Study Using Outpatient Setting to Investigate
the Duration of Effect and Evaluate Further Safety of PrEP-001
Given Prophylactically in Healthy Subjects, Subsequently Challenged
with Human Rhinovirus (HRV-16)
This dose regimen and duration (i.e., durability) study was a
double-blind-placebo controlled study in which there were two days
of dosing with 2 different dosing regimens, followed by viral
challenge (Cohort A: dosing on days -7 and -6, active n=25 and
placebo n=27; Cohort B: dosing on days -4 and -3, active n=24 and
placebo n=26). The study utilised an outpatient setting where
individuals self-monitored symptoms from the time of first dosing
until 8 days post inoculation. Symptoms were self-assessed through
diary cards three times daily (4-point scale, with 10 upper and
lower respiratory and systemic symptoms).
The primary objective of the study was to assess the duration of
prophylactic effect of repeated intranasal dosing with PrEP-001 in
healthy subjects, subsequently challenged with HRV-16, when
compared to placebo, at the two different dosing regimens. The
primary end-point was the difference in the "area under the curve"
of TSS, post-viral challenge, between the treatment arm and placebo
arm, while the secondary end points included severity, peak and
duration of symptoms.
References
1 hVIVO confirms favourable results for PrEP Biopharm's PrEP-001
Phase IIa influenza prophylaxis study (14 June 2016)
2 Total Symptom Score (TSS) is the sum of the total symptom
scores from day 1 to day 8, inclusive, using the 10-point symptom
diary card
3 All five 'zero' TSS subjects were confirmed to be HRV-16
infected
4 Global Initiative for Asthma (GINA). Global strategy for
asthma management and prevention -
updated December 2016; http://www.ginasthma.org/
For further information please contact:
hVIVO plc +44 207 756 1300
Kym Denny (Chief Executive
Officer)
Graham Yeatman (Chief Financial
& Business Officer)
+44 203 021 3933
Media Enquiries / +44 7854 979 420
Colin Paterson (Director of
Marketing, Communication and
Public Relations)
Numis Securities Limited +44 207 260 1000
Michael Meade / Freddie Barnfield
(Nominated Adviser)
James Black / Michael Burke
(Corporate Broking)
FTI Consulting
Simon Conway / Victoria Foster
Mitchell (UK) +44 203 727 1000
John Capodanno / Evan Smith
(US) +1 212 850 5705
Notes to Editors:
hVIVO plc ("hVIVO"), a specialty biopharma company with
discovery and clinical testing capabilities, is pioneering a
human-based analytical platform to accelerate drug discovery and
development in respiratory and infectious diseases. Leveraging
human disease models in flu, RSV and asthma exacerbation, 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 45 clinical
studies, inoculated over 2000 volunteers and has three
first-in-class therapies currently in development with a growing
pre-clinical pipeline.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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