Arrowhead Presents Clinical Data on JNJ-3989 (ARO-HBV) at The International Liver Congress™
- Category: DNA RNA and Cells
- Published on Saturday, 13 April 2019 15:33
- Hits: 426
PASADENA, CA, USA I April 12, 2019 I 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
Oral Presentation Details:
Short term RNA interference (RNAi) therapy in chronic hepatitis B (CHB) using JNJ-3989 brings majority of patients to HBsAg <100 IU/ml
- Presentation Reference: PS-080
- Session: Parallel session: Hepatitis B - drug development
- Session Date and Time: April 12, 2019 at 5:45 p.m. CET
- Authors: Man-Fung Yuen, et al.
Additional details, including the presentation abstract, can be found on the ILC website at https://ilc-congress.eu/. A copy of presentation materials can be accessed by visiting the Events section under the Investors tab of the Arrowhead website.
AROHBV1001 (NCT03365947) is a Phase 1/2 clinical study evaluating the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, as well as the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.
Hepatitis B infection is a life-threatening viral infection of the liver, which can cause cirrhosis — scarring of liver tissue — and liver cancer if the infection becomes chronic. The World Health Organization cites that hepatitis B is a global public health problem with 257 million people living with the disease, resulting in 887,000 deaths in 2015.2 While a preventive vaccine is available, cure rates for those infected remain low and most patients will endure lifelong therapy.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
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1 Jeng et al. 2018 Hepatology 68:425-434
2 World Health Organization (WHO). Hepatitis B. July 2017. Available at: http://www.who.int/mediacentre/factsheets/fs204/en/
SOURCE: Arrowhead Pharmaceuticals