hVIVO plc Initial results for PrEP Biopharm's Flu study (1691W)
April 25 2016 - 1:01AM
UK Regulatory
TIDMHVO
RNS Number : 1691W
hVIVO plc
25 April 2016
For immediate release 7.00am: 25 April 2016
HVIVO PLC
("hVIVO" or the "Company")
hVIVO announces initial results for PrEP Biopharm's PrEP-001
look favourable in Phase IIa influenza prophylaxis study
hVIVO completes Proof of Concept (POC) flu trial in less than a
year
Phase IIa programme on track for completion by end of 2016
hVIVO plc (AIM: HVO), the pioneer of human models of disease,
today announces that initial review of results from the PrEP-001
Phase IIa flu study suggest a favourable study outcome, only eight
months after the study received ethics approval. PrEP-001 is a
nasally administered, broad-spectrum agent that leverages the
innate immune system to prevent upper respiratory tract viral
infections (colds and flus) and is the lead program of PrEP
Biopharm Limited, a new UK biotech company for respiratory
infectious disease products, in which hVIVO acquired a significant
equity stake on 1 November 2015.
The study titled, "A Phase II, Repeated Dose, Double-Blinded,
Randomised, Controlled Study to Examine the Prophylactic Efficacy,
Safety and Tolerability of PrEP-001 in Healthy Subjects
Subsequently Challenged with Influenza A/Perth/16/2009 (H3N2)
Virus" contained 63 subjects and is the first of three Phase IIa
studies to be conducted by hVIVO for PrEP Biopharm. The study's
primary objective focused on assessing the changes in symptoms in
healthy subjects who received PrEP-001 compared to those who
received placebo. The study was held in hVIVO's purpose-built
quarantine unit located in London using hVIVO's flu disease model.
Two additional Phase IIa studies, an asthma study and a dose
ranging durability study, are currently ongoing.
Initial unblinded review of the study's data showed a decrease
in the number of symptoms in subjects in the active treatment group
compared to placebo, the study's primary end point. Initial review
of the safety data was also encouraging, with more adverse events
(AEs) reported in the placebo group than in the active treatment
group. These initial results are subject to detailed statistical
analysis, which will be performed in the coming weeks.
hVIVO CEO Kym Denny commented, "We are delighted to report such
encouraging initial results for the first of our PrEP-001 Phase IIa
studies. While subject to more detailed statistical review and
analysis, these results speak to the potential we saw in the
PrEP-001 study using hVIVO's platform in 2013-14. I look forward to
updating our investors further once these results are
finalised."
Ryan Muldoon, PrEP Biopharm CEO added, "We are encouraged by the
initial results from the PrEP-001 flu study conducted by hVIVO.
Upper respiratory viral infections present an enormous unmet
medical need. PrEP Biopharm is committed to bringing new options to
patients who suffer continuing morbidity and mortality from these
infections."
For further information, please contact:
hVIVO plc +44 207 756 1300
Kym Denny (Chief Executive Officer)
Graham Yeatman (Chief Financial & Business Officer)
Media Enquiries +44 203 021 3933 / +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)
Notes to Editors:
About hVIVO
hVIVO plc ("hVIVO") is a life sciences company pioneering a
technology platform of human disease models to accelerate drug
discovery and development in respiratory and infectious diseases,
including flu, RSV, asthma and common cold. hVIVO has
commercialised four disease models, successfully enrolled over
2,000 subjects and conducted over 40 product validation studies for
a wide range of industry, government and academic clients and
collaborators.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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