Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones

Assembly Biosciences, Inc. recently outlined anticipated progress and milestones for its development pipeline in 2022.

“The forward momentum we expect to demonstrate across our R&D portfolio in the New Year is indicative of the strength of our refined strategy and the deep HBV and virologic drug development expertise and knowledge our team possesses,” said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio. “Over the coming months, we plan to share preliminary on-treatment data from three Phase 2 triple combination studies of our lead investigational core inhibitor candidate, vebicorvir (VBR), with other complementary mechanisms; advance the clinical development of ABI-H3733; and initiate a first-in-human clinical trial of ABI-4334, our newest core inhibitor candidate, with the most potent preclinical profile to date. In addition, later this year we will be announcing exciting new programs to explore and advance novel antiviral mechanisms in HBV and other viruses. We look forward to the opportunities and promise 2022 holds – not only for Assembly Bio, but also for the patients we aim to serve.”

Anticipated Milestones and Events

1H 2022

• Provide updates on strategy and research programs beyond HBV core inhibition to other HBV targets and share plans to explore other viruses
• Complete enrollment for the two ongoing triple combination studies with VBR + NrtI and AB-729, Arbutus Biopharma’s RNAi therapeutic candidate, and with VBR + NrtI + PEG-IFNα
• Initiate triple combination cohort with VBR + NrtI and ATI-2173, Antios Therapeutics’ investigational active site polymerase inhibitor nucleotide (ASPIN)
• Initiate Phase 1b study of ABI-H3733 in patients with chronic HBV infection

2H 2022

• Initiate first-in-human Phase 1a study of ABI-4334, a next-generation core inhibitor optimized for potency against the formation of covalently closed circular DNA (cccDNA)
• Report interim on-treatment data from two triple combination studies: (1) VBR + NrtI and AB-729 and (2) VBR + NrtI and interferon (Peg-IFNα)
• Report initial on-treatment data from triple combination cohort with VBR + NrtI and ATI-2173
• Report initial Phase 1b data for ABI-H3733
• Phase 1a data for ABI-4334 expected as early as year end

Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies for HBV cure and research programs focused on the discovery of additional novel antiviral mechanisms for HBV, and other viral diseases. For more information, visit assemblybio.com.