Positive results achieved in ReViral’s Phase IIa RSV challenge study
ReViral’s RV521 fusion inhibitor produces highly significant reduction in viral load and clinical symptoms
London, UK, 5th February 2018 / ReViral, a UK-based biotech company focused on developing novel compounds targeting respiratory syncytial virus (RSV), today announced successful results from its Phase IIa placebo-controlled challenge trial in healthy adult subjects infected intranasally with respiratory syncytial virus (RSV). The study of RV521, an oral RSV fusion inhibitor, achieved all its primary and secondary endpoints (significantly reduced viral load, reduced total mucus weight and reduced clinical symptoms) compared to placebo.
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.
“RSV infection in children, the immunocompromised and the elderly causes serious disease and there is a significant unmet medical need for treatment.” said John DeVincenzo, MD, Professor of Pediatrics and Professor of Microbiology, Immunology, and Biochemistry, University of Tennessee School of Medicine and Medical Director of the Molecular and Viral Diagnostics Laboratories at Le Bonheur Children’s Hospital. “Based on the reductions in RSV viral load and clinical symptoms, as well as the safety profile observed in this adult challenge study, clinical trials in naturally infected patients should now be expedited.”
Efficacy was evaluated in healthy volunteers who had demonstrated RSV infection before treatment. Among 66 subjects (randomised 2:1, RV521 to placebo), RV521 treatment rapidly reduced viral load to undetectable levels. Mean total mucus weight and total symptom diary score (daily reporting of symptoms such as stuffy nose, cough and sore throat) were also significantly lower for RV521 treated patients.
Safety analysis demonstrated no changes in laboratory-determined safety parameters and a balanced adverse event profile between and within both dose groups and placebo. No treatment-related serious adverse events occurred.
Eddy Littler, ReViral CEO, said, “RV521 has shown best in class properties as an RSV therapeutic including efficacy, dose and safety. The company will now move forward to a clinical study in infants”. The full data will be presented at the American Thoracic Society meeting in San Diego (18-23 May, 2018).
For further information, contact:
Eddy Littler, CEO
T: +44 (0)7789 860994
Sciad Communications, Media Relations
Deborah Cockerill, Managing Partner
T: +44 (0)20 7470 8801
Source: ReViral Ltd.