Arbutus Announces Pipeline Updates and Dosing of the First Subject in the Phase 1a/1b Clinical Trial with AB-101; Cash Runway Extended - Seite 2

The AB-101-001 Phase 1a/1b double-blind, randomized, placebo-controlled, clinical trial is designed to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of AB-101 for up to 28 days in healthy subjects and patients with cHBV.  The trial will be conducted in three parts starting with single ascending doses in up to 64 healthy subjects, followed by multiple ascending doses in up to 40 healthy subjects and culminating with multiple doses in up to 60 patients with cHBV.  Safety and PK/PD assessments will be performed prior to dose escalation in all study parts. Initial data from part one of the clinical trial are expected in the first half of 2024.   

These pipeline updates will not impact the Company’s pending litigations. Arbutus will continue to protect and defend its intellectual property, which is the subject of the on-going lawsuits against Moderna and Pfizer/BioNTech. The Company is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of its patented LNP technology that was developed with great effort and at a great expense, without which Moderna and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful. Document production is currently on-going in the lawsuit against Moderna with the claim construction hearing scheduled for February 7, 2024. There are no updates to the status of the Pfizer/BioNTech lawsuit at this time.

About imdusiran (AB-729) 

Imdusiran 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. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.