JNJ-56136379 JADE 2期研究对慢性乙型肝炎患者的疗效和安全性结

StephenW

                       

Efficacy and Safety Results of the Phase 2 JNJ-56136379 JADE Study in Patients with Chronic Hepatitis B: Interim Week 24 Data                                                                           EASL: 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 (08/27/20) EASL 2020 Aug 27-29 virtual Reported by Jules Levin Harry L.A. Janssen1, Jinlin Hou2, Tarik Asselah3, Henry L.Y. Chan4, Fabien Zoulim5, Yasuhito Tanaka6, Ewa Janczewska7, Ronald Nahass8, Stefan Bourgeois9, Maria Buti10, Pietro Lampertico11, Oliver Lenz12, Thierry Verbinnen12, Joris Vandenbossche12, Willem Talloen12, Michael Biermer12, Ronald Kalmeijer13, Maria Beumont13, Umesh Shukla13 1Toronto General Hospital, Toronto, ON, Canada; 2Nanfang Hospital, Southern Medical University, Guangzhou, China; 3University Paris Diderot, INSERM UMR1149, Hôpital Beaujon, Clichy, France; 4The Chinese University of Hong Kong, Hong Kong SAR, China; 5Hospices Civils de Lyon and Lyon University & INSERM U1052-Cancer Research Institute of Lyon, Lyon, France; 6Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 7University of Silesia, School of Health Sciences in Bytom, Medical University of Silesia, Poland; 8ID Care, Hillsborough, NJ, USA; 9ZNA Jan Palfijn, CPU, Antwerp, Belgium; 10Hospital Universitario Vall d'Hebrón and CIBERHED del Instituto Carlos III, Barcelona, Spain; 11CRC "A. M. and A. Migliavacca" Center for Liver Disease, Division of Gastroenterology and Hepatology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy; 12Janssen Pharmaceutica NV, Beerse, Belgium; 13Janssen Pharmaceuticals R&D, Titusville, NJ, USA

StephenW

由于病毒突破的情况，JNJ-56136379单一疗法将不会进一步发展。
在JNJ-56136379 + NA组合臂中未观察到病毒突破

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Arrowhead and Collaborator Janssen Present Phase 2 Clinical Data on Investigational Hepatitis B Therapeutic JNJ-3989 at The Digital Liver Congress
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Arrowhead and Collaborator Janssen Present Phase 2 Clinical Data on Investigational Hepatitis B Therapeutic JNJ-3989 at The Digital Liver Congress
Aug 28, 2020 at 7:30 AM EDT
PASADENA, Calif. --(BUSINESS WIRE)--Aug. 28, 2020-- 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
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PASADENA, Calif.--(BUSINESS WIRE)--Aug. 28, 2020-- 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.

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tim889

这个cam inhibitor 看来挺容易耐药