Company Announcements

hVIVO plc

("hVIVO" or the "Company")

hVIVO RSV challenge model delivers positive results for novel therapy

·      Human Challenge Study conducted by hVIVO using its industry leading RSV challenge model delivers positive results for Enanta's novel N-protein inhibitor EDP-938

London, UK - 17 June 2019: hVIVO plc (AIM: HVO), an industry leading clinical development services business pioneering human disease models based upon viral challenge, acknowledges the announcement by Enanta Pharmaceuticals, Inc. of positive topline results from an RSV challenge study. The study demonstrated that Enanta's novel N-protein inhibitor, EDP-938, achieved highly statistically significant (p<0.001) reductions in viral load and in resolution of clinical symptoms compared to placebo in healthy adults infected with respiratory syncytial virus (RSV). The study was conducted at hVIVO's specialist clinical facility in London, using its industry leading RSV challenge study protocol.

Dr Trevor Phillips, Executive Chairman, commented:

"We are pleased to have been able to support Enanta in the development of this novel therapy. These positive clinical proof of concept results support the further development of EDP-938. The study conducted by hVIVO highlights the value that can be obtained from challenge studies to rapidly establish clear indications of clinical efficacy and dose-response and deliver supporting safety data in a cost-effective controlled study at an early stage of a product's development. The data also further validate the value of our RSV challenge model that we believe to be the only such RSV model currently commercially available.

The Company's contract pipeline is experiencing a strong demand for RSV challenge study services, which is reflective of the unmet medical need that companies are addressing and the results of this study are further endorsement of the value of the hVIVO challenge model in RSV and the benefit of viral challenge models in clinical development in general."

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Notes to Editors:

hVIVO plc ("hVIVO") is pioneering a human-based clinical trial platform to accelerate drug and vaccine development in respiratory and infectious diseases. Leveraging human disease models in flu, RSV, HRV and respiratory indications, 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 50 clinical studies and inoculated over 2500 volunteers.

Forward-looking statements

This announcement includes statements that are, or may be deemed to be, forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms anticipates, believes, estimates, expects, intends, may, plans, projects, should or will, or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. Any forward-looking statements in this announcement reflect the Group's (or, as the case may be, the hVIVO directors') current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's operations, results of operations and growth strategy. Investors should specifically consider the factors identified in this announcement which could cause actual results to differ before making an investment decision.