S-337395 for RSV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new drug, S-337395, in combating RSV, a virus that can cause serious lung infections, especially in individuals with other health issues. The study will compare the effects of this drug to a placebo, with some participants receiving low or high doses of the drug. It seeks adults who have recently developed RSV symptoms like fever or cough and have ongoing lung or heart issues requiring regular treatment. Participants must not be hospitalized or have any other major infections at the time of joining. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that S-337395, a new drug being tested for RSV (respiratory syncytial virus), is generally safe for people. Studies found that patients who took S-337395 experienced a significant drop in the amount of virus in their bodies, indicating the drug effectively reduced the virus. Importantly, patients tolerated the treatment well, with no major safety issues reported. Although the drug is still under investigation, these results suggest that S-337395 is safe for further research in humans.12345
Why are researchers excited about this trial's treatments?
Most treatments for respiratory syncytial virus (RSV) involve supportive care or antiviral medications like ribavirin. But S-337395 works differently, targeting the virus with a new mechanism of action that researchers are hopeful will be more effective. Unlike traditional options, S-337395 is administered orally, which could make it easier for patients to take. Additionally, having both low and high-dose options allows for flexibility in treatment, potentially optimizing effectiveness while minimizing side effects. Researchers are excited about the potential for quicker symptom relief and an innovative approach to tackling RSV.
What evidence suggests that S-337395 might be an effective treatment for RSV?
Research has shown that S-337395 is a promising new treatment for RSV, a virus affecting the lungs. In earlier studies, patients who received S-337395 had significantly less virus in their bodies, with the treatment reducing the virus by 88.94%. This drug blocks a protein the virus needs to multiply, potentially stopping the virus from spreading in the body. In this trial, participants will receive either a low dose or a high dose of S-337395, or a placebo, to further evaluate its effectiveness in managing RSV infections.12356
Are You a Good Fit for This Trial?
This trial is for adults with RSV symptoms like fever or cough, diagnosed within 72 hours using a rapid test. It's specifically for those at high risk of severe illness, which includes people over 75 years old, or those with chronic lung or heart conditions requiring ongoing treatment. Participants should be medically stable based on their medical history and recent exams.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a low or high dose of S-337395 or placebo BID orally for up to 5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- S-337395
Trial Overview
The study tests the antiviral drug S-337395 against a placebo in nonhospitalized adults who have RSV and are at high risk of developing severe disease. The effectiveness of S-337395 will be measured by how well it controls the virus compared to the placebo.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a low dose of S-337395 BID orally for up to 5 days.
Participants will receive a high dose of S-337395 twice daily (BID) orally for up to 5 days.
Participants will receive matching placebo BID orally for 5 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shionogi
Lead Sponsor
Dr. Isao Teshirogi
Shionogi
Chief Executive Officer since 2008
PhD in Pharmaceutical Sciences from the University of Tokyo
Dr. Takuko Sawada
Shionogi
Chief Medical Officer since 2022
MD from a recognized institution (specific details not found)
Citations
Shionogi Announces Positive Results from Phase 2 Trial of ...
S-337395 is an investigational oral antiviral candidate for RSV infection that inhibits the activity of the L protein, which is essential for virus replication.
NCT07214571 | A Study of S-337395 in Symptomatic ...
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants ...
3.
2minutemedicine.com
2minutemedicine.com/shionogi-and-ube-novel-antiviral-drug-demonstrates-efficacy-in-rsv-patients/Shionogi and UBE: Novel Antiviral Drug Demonstrates ...
RSV patients treated with antiviral drug S-337395 showed statistically significant reduction in viral load; S-337395 is generally safe and ...
4.
contagionlive.com
contagionlive.com/view/shionogi-investigational-rsv-oral-antiviral-reaches-primary-endpoint-for-phase-2-trialShionogi Investigational RSV Antiviral Reaches Primary ...
The company said its oral therapy, S-337395, achieved a 88.94% reduction in viral load.
Evaluate the efficacy, safety and dose-response of S-337395
Treatment with S-337395 will show an antiviral effect demonstrated by a significant reduction in RSV VL-AUC (measured by qRT-PCR) compared to placebo. Group A ...
Status of advanced respiratory syncytial virus antiviral ...
Aerosolized ribavirin is the only antiviral currently FDA approved for the treatment of severe RSV disease in children. However, use is restricted to patients ...
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