Japan records surprise trade deficit in July as exports weaken further
LONDON - Shionogi & Co., Ltd. (TYO:4507) has reported positive outcomes from its Phase 2a human challenge trial for an investigational oral antiviral candidate targeting Respiratory Syncytial Virus (RSV), conducted by hVIVO plc, a leader in human challenge clinical trials. The trial revealed a significant reduction in viral load for the drug S-337395, which has been granted Fast Track designation by the U.S. FDA.
During the randomised, placebo-controlled, double-blind study, healthy volunteers recruited by hVIVO’s FluCamp were administered S-337395 once daily for five days. Results showed an 88.94% reduction in viral load in the highest dose group of the antiviral candidate, meeting the primary endpoint of the trial. Furthermore, this group experienced a statistically significant improvement in clinical symptom scores.
The safety profile of S-337395 was also positive, with no serious or severe adverse events reported. There was no increase in the incidence or severity of adverse events related to the dosage, and no participants discontinued due to adverse events.
Human challenge trials, such as the one conducted by hVIVO, are instrumental in expediting drug development by providing rapid efficacy data and reducing risks in later-stage trials. hVIVO boasts over 30 years of experience in safely conducting such trials for various respiratory viruses, including RSV. The company has carried out 30 RSV challenge studies with around 2,000 volunteers, accelerating the development of numerous RSV antiviral and vaccine candidates.
The success of S-337395 in this trial underscores the potential of human challenge trials in the advancement of new treatments. hVIVO is dedicated to continuing its support of antiviral research through its human challenge models and looks forward to assisting Shionogi in the further development of S-337395.
Dr. Andrew Catchpole, Chief Scientific Officer of hVIVO, commented on the results, emphasizing the significance of human challenge trials in the progress of RSV treatments and the potential of S-337395 to meet the critical demand for effective RSV therapies. The company anticipates ongoing success for Shionogi’s antiviral candidate.
This report is based on a press release statement from hVIVO plc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.