Arrowhead and Collaborator Janssen Present Phase 2 Clinical Data on Investigational Hepatitis B Therapeutic JNJ-3989 at The Digital Liver Congress
JNJ-3989 is a liver-targeted investigational antiviral therapeutic for subcutaneous injection designed to treat chronic HBV (CHB) infection via the ribonucleic acid interference (RNAi) mechanism.
Janssen is currently conducting 48-week phase 2b studies of JNJ-3989 + NA, with or without JNJ-6379 to assess functional cure rates in patients with CHB. JNJ-6379 is an investigational orally administered capsid assembly modulator of the class that forms normal capsid structures (CAM-N). Arrowhead entered into a license and collaboration agreement with Janssen in
- Title: Short-term treatment with RNA interference therapy, JNJ-3989, results in sustained hepatitis B surface antigen suppression in patients with chronic hepatitis B receiving nucleos(t)ide analogue treatment
Edward Gane, et al.
- Type: Oral Presentation
Date and Time:
August 28, 2020at 13:30 CEST
Key points presented include the following:
In the AROHBV1001 study in CHB patients, JNJ-3989 was administered on Days 0, 28, and 56 in combination with daily oral NA treatment
The objectives of this analysis were to assess sustained response in hepatitis B surface antigen (HBsAg), HBV RNA, hepatitis B e-antigen (HBeAg) and hepatitis B core-related antigen (HBcrAg) up to Day 392, 48 weeks after the last JNJ-3989 dose in patients with CHB continuing with NA treatment from Day 0 to end of study
- Sustained responders were classified as those CHB patients with ≥1 log10 IU/mL reduction in HBsAg from Day 0 to Day 392
- The objectives of this analysis were to assess sustained response in hepatitis B surface antigen (HBsAg), HBV RNA, hepatitis B e-antigen (HBeAg) and hepatitis B core-related antigen (HBcrAg) up to Day 392, 48 weeks after the last JNJ-3989 dose in patients with CHB continuing with NA treatment from Day 0 to end of study
- For the first time in patients with CHB, siRNA therapy resulted in sustained, off-treatment ≥1log10 IU/mL reductions in HBsAg through to 48 weeks in 39% of patients after the last JNJ-3989 dose
- Reductions in HBV RNA, HBeAg, HBcrAg were seen across all cohorts, and were more pronounced in HBsAg sustained responders than non-responders
- Three injections of JNJ-3989 administered once every 4 weeks were well tolerated at doses up to 400 mg and appeared to have a good long-term safety profile
- These results support the evaluation of longer durations of treatment with JNJ-3989 + NA, with the objective of providing a functional cure in patients with CHB
A copy of the presentation materials may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.
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