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ReViral to Present Data Showing Absence of Clinical Resistance in Volunteers Infected with RSV then Treated with Sisunatovir (RV521)

Highly encouraging resistance profile of Company’s lead drug
candidate to be presented at the 32nd International Conference on
Antiviral Research (ICAR)

LONDON–(BUSINESS WIRE)–ReViral Ltd., a clinical-stage company focused on developing novel,
anti-viral compounds that target respiratory syncytial virus (RSV),
today announced that new, highly encouraging resistance profile data
from its human challenge study will be delivered in an oral presentation
at the 32nd International Conference on Antiviral Research
(ICAR) to be held 12 – 15 May 2019 in Baltimore, MD. The data
demonstrate that there was no evidence of selection of resistant viruses
in volunteers infected with RSV and subsequently treated with ReViral’s
lead drug candidate sisunatovir (RV521).

ReViral’s presentations at the conference will also include data on
sisunatovir-resistant virus selection in the laboratory that demonstrate
the small number of variants generated are unable to compete with
wild-type RSV. These pre-clinical findings are supported by data from
the RSV challenge model, in which only two variants were detected in
over 50 subjects and these were not associated with any clinical
resistance.

Pre-clinical and clinical studies have shown that sisunatovir is a
best-in-class, highly potent, orally available inhibitor of RSV in adult
volunteers. Sisunatovir is now poised to enter an international
multicentre Phase IIa pediatric trial, which will be followed by a trial
in adult stem cell transplant patients.

Details on the data presentations are as follows:

Title:  

In Vitro and Clinical Resistance Profile of Sisunatovir
(RV521), a Small Molecule Respiratory Syncytial Virus Fusion
Inhibitor in Clinical Development (Poster Session)

Date: Monday 13th May 2019
Time: 12:30-13:30 PM ET
Room: Constellation CDEF, Hyatt Regency Baltimore
 
Title:

In Vitro and Clinical Resistance Profile of Sisunatovir
(RV521), a Small Molecule Respiratory Syncytial Virus Fusion
Inhibitor in Clinical Development (Oral Presentation)

Date: Wednesday 15th May 2019
Time: 3:40 PM ET
Room: Constellation AB, Hyatt Regency Baltimore

Notes to Editors

About ReViral

ReViral is a clinical-stage company focused on developing novel,
anti-viral compounds that target respiratory syncytial virus (RSV).
Founded in 2011, ReViral has an experienced R&D leadership team with a
successful track record in antiviral drug discovery and development. The
company has developed a novel antiviral programme targeting RSV fusion
with highly potent, orally bioavailable inhibitors, strong drug-like
characteristics and good pharmacokinetic properties offering versatility
in the route of administration. The lead candidate sisunatovir completed
a Phase IIa study in adult volunteers showing high potency and excellent
safety. The company also has an RSV replication programme at an earlier
stage of development and plans to expand its pipeline. In August 2018,
ReViral completed a $55 million Series B funding round from a group of
leading venture capital investors jointly led by New Leaf Venture
Partners and Novo Ventures, part of Novo Holdings A/S, with additional
new investment from Perceptive Advisors. Existing investors Andera
Partners, OrbiMed and Brace Pharma Capital also participated in the
fundraise.

About Sisunatovir

Sisunatovir is an orally available small molecule antiviral fusion
inhibitor being evaluated for the treatment of RSV. Sisunatovir blocks
RSV replication by inhibiting RSV F-mediated fusion of RSV to the host
cell. In 2018, sisunatovir generated positive results in a Phase IIa RSV
challenge study in healthy adult volunteers, producing statistically
significant reductions in viral load and clinical symptoms. In Phase I
clinical studies sisunatovir showed excellent exposure with no serious
adverse events. Pre-clinical toxicity tests in adult and juvenile
species showed sisunatovir to have an excellent safety profile with an
attractive margin over therapeutic doses.

About Respiratory Syncytial Virus (RSV)

RSV is a pathogen that infects the human respiratory tract, potentially
leading to bronchiolitis and pneumonia. While most (but not all)
otherwise healthy people recover from the virus, there is an increased
risk of severe disease and death in premature infants, individuals with
certain pulmonary conditions, the elderly and those who are immune
suppressed. Globally RSV is responsible for more than 30 million
infections every year and as many as 200,000 infant deaths. An estimated
2-3% of all infants under 2 years of age are hospitalised with RSV.

For more information, please visit http://www.reviral.co.uk

Contacts

ReViral Ltd
Eddy Littler, CEO
E: elittler@reviral.co.uk
T:
+44 (0) 1438 906761

FTI Consulting (PR Advisors to ReViral)
Irma Gomez-Dib (US)
+1 212 850 5761
Simon Conway (UK) +44 20 3727 1000
Email: reviral@fticonsulting.com

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