Shionogi and UBE: Novel Antiviral Drug Demonstrates Efficacy in RSV Patients
- RSV patients treated with antiviral drug S-337395 showed statistically significant reduction in viral load
- S-337395 is generally safe and well tolerated with no serious adverse events reported in phase 2 data.
The Latest
A recent phase 2, randomized, placebo-controlled, double-blind human challenge study conducted in a joint endeavor by Shionogi and UBE Corporation demonstrated the efficacy and safety of a novel investigational respiratory syncytial virus (RSV) oral antiviral candidate termed S-337395. In this human challenge study, healthy subjects were infected with RSV to investigate the onset of disease and progression of symptoms and viral load. The study saw 114 healthy adults inoculated with RSV and given either S-337395 or a placebo orally once daily over five days. Individuals treated with S-337395 showed a statistically significant reduction in viral load compared to the placebo group. In patients who received the highest dose of S-337395, a reduction rate of 88.94% in viral load was measured in addition to improvement in clinical symptom scores. There were no serious adverse events associated with the antiviral medication. No dose-dependent increases in incidence or severity of adverse events were observed.
Physicians Perspective
RSV is present worldwide but has the greatest impact on vulnerable infants in urban areas. RSV is a common respiratory virus the infects the nose, throat, and lungs that can cause severe illness such as bronchiolitis and pneumonia in children younger than 2 years of age. More recently, literature has shown that there is also a high rate of hospitalizations and mortality from RSV in individuals aged 60 and older. There are estimated to be over 3 million patients with RSV infections in the US annually. Each year in the US, RSV leads to approximately 2.1 million outpatient visits among children younger than 5 years old, and approximately 0.63 million-2.3 million outpatient visits among adults 60 years and older. Current antiviral treatment options for RSV are ineffective and limited. There is a significant unmet medical need in this area.
Molecular Targets
S-337395 was discovered through joint research between Shionogi and UBE corporation. It is a low-molecular weight compound with a novel mechanism that inhibits RNA-dependent RNA polymerase activity of the L protein in RSV which inhibits the transcription and replication of the viral genome. S-337395 is unique to F protein inhibitors because it works by preventing viral proliferation within infected cells rather than preventing new viral infections of cells. This is believed to lead to higher efficacy and more rapid reduction in viral load.
Company History
Shionogi is a leading pharmaceutical manufacturer with a history of over one hundred forty five years, with operations beginning in Doshomachi, Osaka in 1878. The company developed its first proprietary antibiotic, Shinomin and the world’s first oxacephem antibiotic. Shionogi began concentrating its resources on infectious disease, pain treatment and metabolic disease in 2005. The company continues to collaborate with other corporations to develop treatments on based on their principle of protecting people worldwide from the threat of infectious diseases.
UBE corporation is a Japanese chemical company with diverse focuses including the life sciences. Their research and development have led to advancements in small molecule therapeutics.
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