SPY328.73+5.23 1.62%
DIA271.70+3.60 1.34%
IXIC10,913.56+241.30 2.26%

Arrowhead And Collaborator Janssen Highlights Presentation Of Phase 2 Clinical Data On Investigational Hepatitis B Therapeutic JNJ-3989 At The Digital Liver Congress

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced the presentation of Phase 2 clinical data from the AROHBV1001 phase 1/2 study on a double combination of JNJ-3989 (formerly

 · 

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced the presentation of Phase 2 clinical data from the AROHBV1001 phase 1/2 study on a double combination of JNJ-3989 (formerly ARO-HBV) and a nucleos(t)ide analog (NA) with collaborator Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data are being presented in an oral presentation at The Digital International Liver Congress - The Annual Meeting of the European Association for the Study of the Liver (EASL).

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 October 2018 to develop and commercialize JNJ-3989.

Presentation Details:

  • 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
  • Authors: Edward Gane, et al.
  • Type: Oral Presentation
  • Date and Time: August 28, 2020 at 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
  • 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.