ReViral, a UK-based biotech company focused on developing novel compounds targeting respiratory syncytial virus (RSV), announces that the first subjects have been dosed in a Phase IIa challenge study evaluating RV521 as an orally administered treatment for RSV infection.
ReViral expects to report top-line data from this trial in early 2018.
RV521 is a potent, orally available, inhibitor of the RSV fusion (F) protein, with promising pharmaceutical properties. It is currently in development for the treatment of RSV disease in paedriatrics, the elderly and immune-compromised patients.
The trial plans to inoculate approximately 70 adult volunteers with RSV to investigate the efficacy, safety and dose-response of orally delivered RV521 for the treatment of the disease.
The primary endpoint of this double-blind, placebo-controlled study, is a reduction of viral load for RV521 compared with a placebo, as measured by PCR analysis of nasal washes, a standard measure of virus replication in this model.
The trial will be conducted at a site in London, UK, and will provide data to inform further development and commercial strategy.
“Dosing our first subjects in this proof of concept study is a major step forward in the evaluation of RV521 as a novel therapy for RSV infected patients, an area of significant unmet medical need,” said Eddy Littler, PhD, CEO of ReViral.
“The Phase I clinical data generated to date for RV521 makes it a promising best-in-class treatment option. We look forward to the results of this challenge study and expect to report top-line results in early 2018.”
Previously, ReViral conducted a UK-based Phase I safety and pharmacokinetic (PK) study of RV521.
In the multiple ascending dose (MAD) phase, groups of eight subjects were dosed with either RV521 (at doses of 175, 250 or 350 mg bid) or a placebo (3:1 ratio) for 5 consecutive days.
There were no significant adverse events reported in any subject at any dose level. Optimal RV521 exposure was achieved after the first dose, and pharmacokinetic (PK) parameters were consistent with predicted values modelled from the single ascending dose (SAD) data.