Arrowhead Has Phase 1/2 Data on JNJ-3989 (ARO-HBV) at Intl Liver Congress

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced the presentation of clinical data from an ongoing Phase 1/2 study (AROHBV1001) of JNJ-3989 (formerly ARO-HBV), a third-generation subcutaneously administered RNA interference (RNAi) therapeutic candidate being developed as a potential treatment for patients with chronic hepatitis B virus (HBV) infection, at The International Liver Congress™ 2019 (ILC), the annual meeting of the European Association for the Study of the Liver (EASL).

Arrowhead entered into a license agreement in October 2018 with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize ARO-HBV.

Key results from this interim analysis include the following:

• JNJ-3989 rapidly reduced hepatitis B surface antigen (HBsAg) in patients that had 24 weeks or more of HBsAg assay results (n=40) to thresholds possibly associated with improved chances of HBsAg seroclearance¹ in many patients, after only 3 doses
  • 100% of patients (40 of 40) achieved ≥1.0 Log10 IU/mL HBsAg reduction
  • 88% of patients (35 of 40) achieved HBsAg <100 IU/mL
  • 43% of patients (17 of 40) achieved HBsAg <10 IU/mL
  • 13% of patients (5 of 40) achieved HBsAg <1 IU/mL
• JNJ-3989 reduced all measurable viral products, including HBsAg in hepatitis B e-antigen (HBeAg) positive or HBeAg negative patients
• JNJ-3989 administered subcutaneously was well tolerated at doses up to 400 mg in all chronic hepatitis B (CHB) patients in cohorts 2b-11 (n=56)
  • 168 total doses administered to 56 CHB patients (cohorts 2b through 11)
  • No drug related serious adverse events (SAE) reported
    • Unrelated SAE of menorrhagia
    • Unrelated SAE of anxiety/depression
  • All patients received all 3 scheduled doses; No dropouts
  • No dose related pattern of adverse changes in laboratory values (e.g. ALT, AST, total bilirubin, creatinine)
  • 17 total AEs at injection site (10% of injections) reported (e.g. erythema, tenderness, bruising), all were mild

https://www.marketscreener.com/ARROWHEAD-PHARMACEUTICALS-26864651/news/Arrowhead-Pharmaceuticals-Presents-Clinical-Data-on-JNJ-3989-ARO-HBV-at-The-International-Liver-28398315/