Arrowhead and Janssen Initiate Triple Combination Cohort in Chronic HBV Study with RNAi Therapeutic JNJ-3989 (ARO-HBV)

April 25, 2019/BioonBIOON/--Arrowhead Pharmaceuticals, a clinical-stage RNAi therapeutics company, recently announced that patient dosing has commenced in a new triple-combination cohort (Cohort 12) of its ongoing Phase I/II clinical study (ARO-HBV-1001) in patients with chronic hepatitis B virus (HBV) infection. The therapeutic regimen for this cohort includes JNJ-3989 (formerly ARO-HBV) and other undisclosed agents selected by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. With the initiation of this new cohort, Arrowhead Pharmaceuticals received a $25 million milestone payment from Janssen Pharmaceuticals.

ARO-HBV is currently being developed as a potential curative therapy for individuals with chronic hepatitis B virus (HBV) infection. ARO-HBV silences all HBV gene products and intervenes upstream of the reverse transcription process targeted by standard-of-care nucleotide and nucleoside analogs, thereby enabling the body’s innate immune defenses to clear the virus and achieve a functional cure.

Dr. Christopher Anzilone, President and Chief Executive Officer of Arrowhead Pharmaceuticals, stated, “Both Arrowhead and Janssen are committed to advancing the development of transformative therapies, enabling patients with chronic hepatitis B virus infection to achieve higher rates of functional cure within a limited treatment duration. The initiation of this new triple-combination cohort in our ongoing ARO-HBV1001 study has the potential to rapidly generate valuable data.”

AROHBV1001 (NCT03365947) is a Phase I/II clinical study evaluating the safety, tolerability, and pharmacokinetic profile 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 hepatitis B.

In October 2018, Arrowhead Pharmaceuticals entered into a license and collaboration agreement with Janssen Pharmaceuticals for the development and commercialization of ARO-HBV. Under the initial terms of this HBV license agreement, Arrowhead was eligible to receive a $50 million milestone payment associated with Phase II studies. Arrowhead and Janssen subsequently amended the HBV license agreement to accelerate the payment of $25 million of the $50 million Phase II milestone upon the initiation of Cohort 12 of the AROHBV1001 study. Arrowhead remains eligible to receive the remaining $25 million following Janssen’s initiation of the Phase II study.

Hepatitis B is a life-threatening viral infection of the liver that, if it becomes chronic, can lead to cirrhosis (scarring of liver tissue) andLiver CancerThe World Health Organization (WHO) states that hepatitis B is a global public health issue, with 257 million people living with the disease and 887,000 deaths attributed to it in 2015. Although preventive vaccines are available, the cure rate for infected individuals remains low, and most patients will require lifelong treatment.(Bioon.com)

Original Source:Arrowhead Begins Triple Combination Cohort in Chronic HBV Patients and Earns $25 Million Milestone Payment from Janssen