hVIVO announces initial results for PrEP Biopharm’s PrEP-001 look favourable in Phase IIa influenza prophylaxis study

April 25, 2016 7:29 am

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, 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

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