RNS 26/3/1826 Mar 2018 10:55
hVIVO plc
Initial results from a Phase IIb study of FLU-v
RNS Number : 8407I
hVIVO plc
26 March 2018
For immediate release 7.00am: 26 March 2018
HVIVO PLC
("hVIVO" or the "Company")
hVIVO announces initial results from a Phase IIb study of FLU-v, a first-in-class universal flu vaccine candidate
hVIVO plc (AIM: HVO) today announces encouraging initial results from a Phase IIb study examining FLU-v as a potential universal vaccine against influenza (flu). Preliminary analysis of the primary endpoint revealed a trend to statistical significance, with further testing of samples ongoing that could affect the final outcome. In addition, the study demonstrated a statistically significant reduction in overt flu symptoms in treated subjects in one arm of the trial (p=.02). Importantly, this vaccine candidate is designed to minimise the impact of the virus by reducing symptoms - potentially relegating flu to a much milder disease - through stimulating an immune response mediated through T-cells, in contrast to seasonal flu vaccines, that prevent infection through antibody protection. The Company believe this is the first time that any universal flu vaccine candidate has demonstrated a statistically significant reduction in a symptom measure for flu in humans in a controlled clinical study.
FLU-v is being developed by Imutex Limited, hVIVO's 49% joint venture with PepTcell Limited, trading as the SEEK Group ("SEEK").
The FLU-v Challenge Study
The FLU-v Phase IIb flu challenge study (ClinicalTrials.gov Identifier: NCT03180801) was part of the collaboration between PepTcell Limited and the National Institute of Allergy and Infectious Diseases, part of the US National Institute of Health (NIH). In this double-blind placebo-controlled single-site study, conducted at hVIVO's quarantine facilities, 123 volunteers were randomised to one of two FLU-v plus adjuvant dosing regimen arms1 or a placebo plus adjuvant arm. Given the novel putative mechanism of action of FLU-v, the study employed a panel of study endpoints allowing the Company and the NIH to explore broadly the most relevant efficacy endpoints for future clinical development. These included composite endpoints involving symptom scores and lab-determined biomarkers, such as viral load, as well as symptom-based endpoints that are suited to FLU-v's mechanism of action.
The primary endpoint, a novel composite score combining the occurrence of one symptom of flu-like illness and changes in viral load, trended to statistical significance in the single FLU-v dose arm versus placebo when using qPCR to determine viral load. The NIH is currently independently evaluating, as a prespecified part of this study, this primary endpoint using the more multifaceted Luminex platform (the platform on which the study powering was derived) to determine viral load. Results of these tests could impact the final result. This data will