Assembly Biosciences outlines planned milestones for pipeline development in 2022

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SOUTH SAN FRANCISCO, Calif., January 4, 2022 (GLOBE NEWSWIRE) – Assembly Biosciences (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapies targeting hepatitis B virus (HBV) and other diseases virales, today described the forecast progress and milestones for its development pipeline in 2022.

“The forward momentum we expect to demonstrate across our R&D portfolio over the new year is indicative of the strength of our refined strategy and the in-depth expertise and knowledge in the development of virologic and anti-HBV drugs that our team has, ”said John McHutchison, AO, MD, chief executive officer and president of Assembly Bio. “Over the next few months, we plan to share preliminary treatment data from three phase 2 triple combination studies of our leading research inhibitor candidate, vebicorvir (VBR), with other complementary mechanisms; to advance the clinical development of ABI-H3733; and launch a first human clinical trial of ABI-4334, our newest core inhibitor candidate, with the most potent preclinical profile to date. Additionally, 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 that 2022 holds – not only for Assembly Bio, but also for the patients we aim to serve. “

Milestones and planned events

1H 2022

  • Provide updates on research strategy and agendas beyond inhibiting the heart of HBV to other HBV targets and share plans to explore other viruses
  • Full registration for the two ongoing triple combination studies with VBR + NrtI and AB-729, the RNAi therapeutic candidate from Arbutus Biopharma, and with VBR + NrtI + PEG-IFNα
  • Launch a triple combination cohort with VBR + NrtI and ATI-2173, the experimental active site polymerase inhibitor nucleotide (ASPIN) from Antios Therapeutics
  • Initiate phase 1b study of ABI-H3733 in patients with chronic HBV infection

2H 2022

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

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

Forward-looking statements
The information contained in this press release contains forward-looking statements which are subject to certain risks and uncertainties which could cause actual results to differ materially. These risks and uncertainties include: Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s clinical collaboration agreements, within the currently scheduled timelines; safety and efficacy data from clinical studies may not support further development of Assembly Bio’s product candidates; clinical and non-clinical data presented at conferences may not differentiate Assembly Bio’s product candidates from candidates from other companies; the results of non-clinical studies may not be representative of the behavior of the disease in a clinical setting and may not be predictive of the results of clinical studies; the continued development and commercialization of Assembly Bio’s HBV product candidates, if successful, in Chinese territory will depend on and be subject to Assembly Bio’s collaboration agreement governing its HBV-related activity in Chinese territory; the ability of Assembly Bio to maintain the financial resources necessary to pursue its clinical studies and finance its commercial activities; any impact that the COVID-19 pandemic may have on Assembly Bio’s activities and operations, including the initiation, registration and continuation of its clinical studies or the timing of discussions with regulatory authorities; and other risks identified from time to time in Assembly Bio’s reports filed with the United States Securities and Exchange Commission (the SEC). You are encouraged to consider statements that include the words may, will, could, could, should, could, believes, hopes, estimates, plans, potential, expects, plans, anticipates, intends, continues, foresees, conceived, objective or negative of these or other comparable words are uncertain and forward-looking. Assembly Bio intends that such forward-looking statements will be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information on the risks and uncertainties of Assembly Bio is further detailed under the heading “Risk Factors” in the documents filed by Assembly Bio with the SEC, including its most recent annual report on Form 10- K, quarterly reports on Form 10-Q and current reports on Form 8-K. Unless required by law, Assembly Bio assumes no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investor and Company:
Lauren Glaser
Senior Vice-President, Investor Relations and Corporate Affairs
(415) 521-3828
[email protected]

Media:
Sam Brown Inc.
Audra Friis
(917) 519-9577
[email protected]

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