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Arbutus Biopharma Provides Update on the Phase 2A Combination Trial with AB-729 and a Capsid Inhibitor

Triple combination clinical trial evaluating AB-729, an RNAi therapeutic, vebicorvir, Assembly Biosciences’ core inhibitor, and nucleos(t)ide analog continues with data expected in 2H 2022

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Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced that while its partner, Assembly Biosciences, has decided to discontinue development of its investigational hepatitis B virus core inhibitor candidate vebicorvir (VBR), it plans, in consultation with Assembly Biosciences, to continue dosing patients in the Phase 2a triple combination clinical trial evaluating its proprietary RNAi therapeutic, AB-729, VBR and nucleos(t)ide analogue (NA) therapy for the treatment of patients with chronic HBV infection (cHBV). Preliminary data from the trial are expected in the second half of 2022.

William Collier, President and Chief Executive Officer of Arbutus, commented, “While we respect Assembly’s decision to discontinue clinical development of VBR, we believe that it is premature to make any conclusions about any results in this triple combination clinical trial.”

He added, “We intend, in collaboration with Assembly, to continue the clinical trial in order to fully and accurately assess the results. The results from this trial coupled with the additional data we anticipate collecting from our capsid inhibitor program will help inform our go-forward combination strategy in the development of cHBV treatments.”

Mr. Collier added, “In addition, we continue to believe that AB-729 is positioned to become a cornerstone agent in potential curative combination treatments for cHBV.”

The randomized, multi-center, open-label Phase 2a clinical trial was designed to enroll approximately 60 virologically-suppressed patients with HBeAg negative chronic HBV to evaluate the safety, pharmacokinetics, and antiviral activity of the triple combination of vebicorvir, AB-729 and an NA compared to the double combinations of vebicorvir with an NA and AB-729 with an NA. Patients are dosed for 48 weeks with vebicorvir (300 mg orally once daily) and AB-729 (60 mg every 8 weeks), with a 48-week follow-up period. The primary objective of the trial is to evaluate the safety and tolerability of the triple combination, while secondary objectives of the trial include evaluating the effect of the triple combination in reducing HBV viral biomarkers such as HBV DNA, HBV pgRNA and HBsAg.

About AB-729

AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated while providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. AB-729 is currently in multiple Phase 2a clinical trials.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 290 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases.

Their current focus areas include Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses. In HBV, they are developing a RNAi therapeutic, an oral capsid inhibitor, an oral PD-L1 inhibitor, and oral RNA destabilizer that we intend to combine with the aim of providing a functional cure for patients with chronic HBV by suppressing viral replication, reducing surface antigen and reawakening the immune system.

The company believes its lead compound, AB-729, is the only RNAi therapeutic with evidence of immune re-awakening. It is currently being evaluated in multiple phase 2 clinical trials. The company also has an ongoing drug discovery and development program directed at identifying novel, orally active agents for treating coronavirus (including SARS-CoV-2). In addition, they are exploring oncology applications for our internal PD-L1 portfolio.

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