The trial enrolled patients with non-cirrhotic, Hepatitis B e antigen positive or negative, chronic hepatitis B. Credit: Peakstock / Shutterstock.

Virion Therapeutics has reported encouraging safety outcomes from the first-in-human Phase IB clinical study of VRON-0200, a checkpoint modifier immunotherapy being analysed as a functional cure for chronic hepatitis B virus (HBV) infection.

The multicentre, open-label, dose-escalation, prime only, and prime plus boost therapeutic vaccination trials are designed to assess the therapy’s tolerability, safety, and immunological responses.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The trial included non-cirrhotic, Hepatitis B e antigen (HBeAg) positive or negative, chronic hepatitis B patients who are currently on nucleos(t)ide antiviral therapy and have HBV DNA levels below 40IU/mL and HBsAg levels under 500IU/mL.

Virion dosed the first patients in the trial last October.

This dose escalation study comprised two cohorts, with cohort one receiving a low dose of VRON-0200 and cohort two subjects being administered a high dose.

See Also:

Subjects within each cohort are randomised to receive either an intramuscular injection as a prime vaccination only or as a prime and boost regimen.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to the initial results obtained from the first ten subjects, the immunotherapy was safe and well-tolerated without any significant adverse events reported.

Furthermore, no clinically relevant abnormalities were observed in laboratory tests, electrocardiograms (ECGs), or vital signs.

Preclinical data suggest that VRON-0200, through checkpoint modification, could amplify and enhance T cell responses, including those not normally activated during chronic HBV infection, thereby improving viral control.

Virion Therapeutics COO Dr Sue Currie said: “Finding a treatment for chronic HBV-infected patients will almost assuredly require an immune-based component to help control the infection.

“These VRON-0200 data—the first ever for a checkpoint modifier containing T cell vaccine of any kind—represent a critical first step in Virion’s mission to bring safe, well-tolerated, and easy-to-administer interferon-sparing functional cure immunotherapy to HBV-infected patients worldwide.

“We look forward to sharing additional safety and the first-ever immunogenicity data from this trial later this year.”