Assembly Biosciences to Present Positive Phase 1a Safety, Tolerability and Target Engagement Data for ABI-6250 at AASLD The Liver Meeting® 2026

SOUTH SAN FRANCISCO, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral and liver diseases, today announced that two posters featuring new Phase 1a data from its ABI-6250 program will be presented at The Liver Meeting® 2026, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 5-9, 2026, in Denver, Colorado.

“The Phase 1a findings support ABI-6250’s safety profile and demonstrate potent target engagement, and we are pleased the pharmacodynamic analysis was recognized as a Poster of Distinction,” said Anuj Gaggar, M.D., Ph.D., chief medical officer of Assembly Bio. “We look forward to sharing these results with the hepatology community as we prepare to advance ABI-6250 into Phase 2 studies in both chronic HDV infection and cholestatic liver diseases.”

The presentations will include safety, tolerability and pharmacodynamic findings from the randomized, blinded Phase 1a study of ABI-6250 in healthy participants. ABI-6250 was well tolerated at the doses evaluated, with no serious adverse events reported, and demonstrated dose-dependent, reversible increases in total and conjugated bile acids consistent with sodium taurocholate co-transporting polypeptide (NTCP) target engagement. The Phase 1a findings support Assembly Bio’s plans to initiate Phase 2 studies in patients with chronic hepatitis delta virus (HDV) infection in the fourth quarter of 2026 and in patients with cholestatic liver diseases, focused on primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), in the first quarter of 2027.

Details of the presentations are as follows:

Poster of Distinction Title: Oral NTCP Inhibitor ABI-6250 Elevates Bile Acids in a Randomized, Blinded, Phase 1a Study in Healthy Subjects
Presenter: Edward J. Gane, MD, FAASLD, University of Auckland
Publication Number: 3197

• Session: Hepatitis – Other Infections
• Date and Time: November 7, 2026; 1:00 – 2:00 p.m. MT
  

Poster Title: The Safety and Tolerability of ABI-6250, an Orally Administered NTCP Inhibitor in Healthy Participants
Presenter: Edward J. Gane, MD, FAASLD, University of Auckland
Publication Number: 3204

• Session: Hepatitis – Other Infections
• Date and Time: November 7, 2026; 1:00 – 2:00 p.m. MT
  

Assembly Bio intends to make the posters available on the “Events & Presentations” page in the “Investors” section and on the “Publications” page in the “Pipeline” section of its website at www.assemblybio.com.

About ABI-6250
ABI-6250 is an investigational oral small-molecule inhibitor of the sodium taurocholate co-transporting polypeptide (NTCP), a membrane protein selectively expressed on hepatocytes that facilitates bile acid transport into cells and also serves as the receptor for hepatitis B virus (HBV) and hepatitis delta virus (HDV) to enter hepatocytes. Assembly Bio is developing ABI-6250 for the treatment of chronic HDV infection, where the targeting of NTCP blocks viral infection and is a clinically validated mechanism. ABI-6250 is also being evaluated in cholestatic liver diseases, such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), where bile acid accumulation in the liver drives liver inflammation and liver injury. The targeting of NTCP by ABI-6250 blocks the uptake of bile acids into liver cells.

About Assembly Biosciences
Assembly Biosciences is a biotechnology company developing innovative small-molecule therapeutics aimed at advancing the treatment paradigm of serious viral and liver diseases and improving the lives of patients worldwide. Led by an accomplished leadership team in antiviral and liver disease drug development, Assembly Bio is committed to improving outcomes for people living with the chronic impacts of herpesvirus, hepatitis delta virus (HDV) infections, cholestatic liver diseases and hepatitis B virus (HBV). For more information, visit assemblybio.com.

Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, including studies conducted by Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of product candidates; clinical and nonclinical data may not differentiate product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to 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 about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings 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. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Investors:
Patrick Till
Meru Advisors
(484) 788-8560
investor_relations@assemblybio.com

Media:
Mike Beyer
Sam Brown LLC
(312) 961-2502 
ASMBMedia@sambrown.com