Clinical Study Guide for HBV Patients
This guide serves as an overview of a new clinical study for Tune-401 – the first approach to the treatment of chronic Hepatitis B Virus infection that incorporates epigenetic editing technology.
What is Hepatitis B?
Chronic Hepatitis B is a serious and potentially deadly liver disease, caused by long-term infection with the Hepatitis B Virus (HBV).
The virus can lie dormant inside liver cells for years, making it hard for your immune system to see it and combat it.
Chronic HBV is sometimes called ‘the silent killer’, because it can create inflammation and liver damage without making you feel obviously sick - especially in earlier stages.
HBV affects over 250 million people worldwide
2 out of every 3 people with chronic HBV do not know they have it
How is it currently treated?
There are several existing treatments already available for HBV – including targeted antivirals (such as Viread®) and antibodies that can limit the activity of the virus and slow the progress of liver disease.
But none of these treatments stops the disease outright. Once you stop taking the drug, the virus quickly returns to full activity, and progressive liver damage and disease resumes.
Eventually, liver transplant becomes the last remaining option for treatment.
Effects of Chronic HBV
HBV causes liver damage that can go unnoticed, but worsens over time
Each day, ~3500 people die of cirrhosis, liver failure, and cancers associated with chronic HBV
What is Tune-401,
and how does it work?
TUNE-401 is a new treatment approach that aims to silence virus DNA in liver cells, in an attempt to achieve a functional cure for chronic HBV.
The Hepatitis B Virus hijacks the cell machinery inside liver cells to make copies of itself and continually re-infect the liver.
But HBV cannot copy itself or reinfect cells if essential parts of its DNA are silenced and blocked off from that machinery.
Tune-401 precisely targets virus DNA and tags it with epigenetic (“over-gene”) marks which instruct the cell machinery to skip it or pass it by. This effectively prevents the cell from assembling new viral bodies, which renders the virus helpless and inactive.
Tune-401 consists of a coded RNA molecule wrapped in a fatty shell made of Lipid Nanoparticles (LNP) . It is structured much like the COVID-19 vaccine, but is delivered via intravenous drip, rather than an injection.
Once inside the body, the LNP shell travels to the liver and releases the RNA into liver cells. The cells then use the RNA like a blueprint to build speciallydesigned proteins that bind to virus DNA and silence it, throughout the liver.
In preclinical (animal) testing, a single dose of Tune-401 was shown to silence viral DNA almost completely in every liver cell that received it.
This and other data suggests that Tune-401 has the potential to be the first, lasting, functional cure for chronic HBV.
The study will run over 2 years (104 wks) It begins with the screening and selection of eligible participants a month before the study starts. This done, accepted participants will be given a single dose of Tune-401 on Day 1, and closely observed with daily and weekly check-ins from week 1-20. Thereafter, participants will attend monthly check-ins to assess drug impact, liver function, and overall health from weeks 20-104.
What are the potential risks and benefits?
Tune-401 is an investigational drug that has not yet been approved for the treatment of HBV in New Zealand. Since no clinical data are currently available, the precise effects and potential side effects are not yet known.
Tune-401 has the potential to control HBV effectively - perhaps permanently - with a single dose of the drug. But for some patients it may not last, may work less well, or may not work at all.
Using Lipid Nanoparticles (LNPs) to deliver drugs like Tune-401 can create liver toxicity, immune reactions and Infusion-Related Reactions (IRRs) in some patients. Although typically mild and transient, symptoms may range from headache and nausea to acute allergic reactions.
For this reason, participants will be carefully monitored throughout the study for these and other effects.
How can I find out more?
To find out more - including Frequently Asked Questions and eligibility requirements for participants - scan the QR code to access the official study website.
123 Somewhere St., This City, NZ 12345
+123-456-7890
www.tuneHBVtrial.com
info@tuneHBVtrial.com