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Arrowhead Collaborator Janssen Begins REEF-1 Phase 2b Combination Study in Patients with Chronic Hepatitis B Infection
Aug 28, 2019 at 7:30 AM EDT
- Arrowhead earns $25 million milestone payment in connection with trial initiation PASADENA, Calif. --(BUSINESS WIRE)--Aug. 28, 2019-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that Janssen Pharmaceuticals, Inc. , part of the Janssen Pharmaceutical Companies of Johnson &
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- Arrowhead earns $25 million milestone payment in connection with trial initiation
PASADENA, Calif.--(BUSINESS WIRE)--Aug. 28, 2019-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has begun dosing in a Phase 2b study (REEF-1) of different combination regimens, including JNJ-3989 (formerly ARO-HBV), and/or JNJ-6379, and a nucleos(t)ide analog (NA) for the treatment of chronic hepatitis B virus infection. In connection with the start of this study, Arrowhead earned a $25 million milestone payment from Janssen.
JNJ-3989 is a liver-targeted investigational antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via the ribonucleic acid interference (RNAi) mechanism. 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 ARO-HBV.
Christopher Anzalone, Ph.D., president and chief executive officer at Arrowhead, said: “Patients with chronic hepatitis B infection are in need of new medicines that improve functional cure rates with finite treatment regimens. We are thrilled that JNJ-3989, formerly ARO-HBV, is one of the agents being investigated in Janssen’s REEF-1 triple combination Phase 2b study.”
REEF-1 (NCT03982186) is a Phase 2b, multicenter, double-blind, active-controlled, randomized study to investigate the efficacy and safety of different combination regimens, including JNJ-3989, JNJ-6379, NA, and/or placebo in patients with chronic hepatitis B virus infection. The study is planned to include up to 450 patients who will be randomized to receive up to 48 weeks of treatment.
Hepatitis B infection is a life-threatening viral infection of the liver, which can cause cirrhosis — scarring of liver tissue — and liver cancer after prolonged period of chronic infection. The World Health Organization cites that hepatitis B is a global public health problem affecting 292 million people worldwide.1 While a preventive vaccine is available, cure rates for those infected remain low and most patients will endure lifelong therapy. |
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发表于 2019-8-28 19:44
