News Article
May 14, 2019
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, UK, 14th May 2019: 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

Ends

For more information, please contact:

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

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.