• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » ReViral initiates phase I trial for respiratory syncytial virus

ReViral initiates phase I trial for respiratory syncytial virus

November 1, 2016
CenterWatch Staff

ReViral, an antiviral drug discovery and development company developing innovative therapies against Respiratory Syncytial Virus (RSV), has initiated a phase I clinical trial for RV521, its novel orally-active small molecule inhibitor of RSV fusion. RSV infection is an area of significant unmet medical need and RV521 is being developed to treat RSV in patients with severe disease including neonates, the elderly, the immunocompromised and those with underlying cardiovascular or respiratory disease.

Rachel Harland, COO of ReViral, said, “We’re very pleased to have initiated our phase I study on RV521 and eagerly await the demonstration that the drug is suitable for progression to further clinical studies in infected patients.”

Eddy Littler, CEO of ReViral, said, “The progression of RV521 to the clinic is a significant achievement for the Company and marks a major step forward in developing a potential new therapy against RSV. We’re also progressing other exciting early-stage programs against RSV based on different mechanisms than that of RV521."

ReViral’s RV521 phase I clinical trial will evaluate the safety, tolerability, and pharmacokinetics of single ascending and multiple ascending oral doses of RV521, as well as the effect of food on drug absorption. The trial will enroll up to 110 healthy volunteers, including some of Japanese origin. Each year, on average, in the U.S., RSV leads to 57,527 hospitalizations among children younger than five years old; 2.1 million outpatient visits among children younger than five years old; 177,000 hospitalizations and 14,000 deaths among adults older than 65 years. By 2024 current estimates suggest that the worldwide RSV market will be worth over $2 billion (GlobalData, 2016).

In preclinical studies, RV521 has been shown to potently inhibit RSV replication in both cultured human cells and in in vivo models. Moreover, during in vitro studies, only low levels of virus resistance to RV521 were observed. Preclinical studies demonstrated that RV521 has good exposure and low toxicity. Altogether these observations support the potential of RV521 in the treatment of infection in all susceptible populations.

Upcoming Events

  • 17May

    Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing