hVIVO plc (LON:HVO), a fast-growing early-stage Contract Research Organisation (CRO) and the world leader in human challenge clinical trials, has noted the announcement by Shionogi & Co., Ltd. (Shionogi), reporting positive results from a Phase 2a Respiratory Syncytial Virus (RSV) human challenge trial (HCT) conducted by hVIVO. The trial demonstrated a significant reduction in viral load for Shionogi’s investigational oral RSV antiviral candidate, S-337395.
S-337395, which has received Fast Track designation from the U.S. Food and Drug Administration (FDA), was evaluated in a randomised, placebo-controlled, double-blind human challenge trial involving healthy volunteers recruited by hVIVO’s volunteer recruitment arm, FluCamp. The antiviral efficacy and safety of S-337395 were evaluated when administered orally once daily for five days.
The S-337395 treatment group showed a statistically significant reduction in viral load compared to the placebo group, achieving the primary endpoint. In the highest dose group of S-337395, there was an 88.94% reduction in viral load (P<0.0001), and also a statistically significant improvement in clinical symptom scores. Additionally, S-337395 was generally safe and well tolerated, there were no serious or severe adverse events, and no dose-dependent increase in incidence or severity of adverse events. No participants discontinued due to adverse events.
