hVIVO confirms favourable results for PrEP Biopharm’s PrEP-001 Phase IIa influenza prophylaxis study

June 15, 2016 12:53 pm

PrEP-001 phase IIa favourable results indicate Proof of Concept in an influenza prevention model. Coupled with previous rhinovirus prevention studies, these data highlight PrEP-001’s pan-viral prophylaxis potential.

hVIVO plc (AIM: HVO), the pioneer of human models of disease, confirms favourable results were achieved in the PrEP-001 Phase IIa influenza study, indicating proof of concept (POC) of PrEP-001’s prophylactic effect. Initial study results were previously announced in April 2016. 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 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 influenza disease model. Two additional Phase IIa studies, a challenge study in asthmatic patients and a dosing study, are currently ongoing.

Similar to previous PrEP-001 phase IIa results obtained in a rhinovirus challenge model, final unblinded review of the influenza study’s data confirmed a decrease in the number of symptoms in subjects in the active treatment group compared to placebo. Review of safety data confirmed encouraging safety results.

Full results of the trial will be presented at upcoming scientific conferences and submitted for publication in peer-reviewed journals.

hVIVO CEO Kym Denny commented, “We are delighted to report the Proof of Concept for PrEP-001 in influenza, indicating PrEP-001’s potential to have a prophylactic effect across a range of respiratory viruses. With additional phase IIa studies already underway, I look forward to relaying further study results on PrEP-001 in the future.”

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.


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