Assembly Biosciences Unveils Hepatitis D Virus Entry Inhibitor Data at EASL 2024

June 5, 2024 – Assembly Biosciences, Inc. (Nasdaq: ASMB), a company at the forefront of developing innovative treatments for serious viral diseases, has unveiled new preclinical data for its hepatitis D virus (HDV) entry inhibitor candidate, ABI-6250. This announcement was made during a poster presentation at the European Association for the Study of the Liver (EASL) Congress held in Milan, Italy, from June 5-8, 2024.

The presentation, titled “Preclinical profiling of ABI-6250, a novel orally bioavailable small-molecule therapeutic candidate for the treatment of chronic hepatitis D,” showcased data that supports progressing ABI-6250 to Phase 1 clinical trials.

Chronic HDV infection is acknowledged as the most severe form of viral hepatitis, leading to conditions such as liver cirrhosis, liver cancer, decompensated liver disease, and potentially death. ABI-6250 functions by obstructing HDV's entry into cells through inhibition of the sodium taurocholate cotransporting polypeptide (NTCP) bile acid transporter, a target validated in clinical settings.

Preclinical results highlighted during the presentation show that ABI-6250 can significantly inhibit HDV infection at low nanomolar concentrations across the most common genotypes (HDV-1, -2, and -3) in HepG2-NTCP cells. Additionally, ABI-6250 was shown to effectively impede NTCP-mediated bile acid uptake while demonstrating selectivity for the NTCP bile transporter over other transporters in vitro. In vivo studies further confirmed that ABI-6250 increased total bile acids, indicating successful NTCP target engagement without elevating biomarkers linked to the inhibition of other transporters. This data not only underscores the in vitro selectivity but also provides a biomarker for target engagement in upcoming Phase 1a studies. The preclinical pharmacokinetic profile of ABI-6250 supports its potential for low, once-daily oral dosing in individuals with chronic HDV.

Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio, remarked, “Chronic HDV infection is a severe global health issue with limited treatment options. The promising preclinical data for ABI-6250 presented at EASL reinforce its potential as a once-daily oral therapy, a significant step forward similar to advancements seen in treatments for chronic viral infections like hepatitis B and HIV. We are excited to advance ABI-6250 into clinical trials later this year and continue sharing insights with the liver disease community.”

Assembly Bio plans to make the presentation available on the “Events & Presentations” section of its website. Currently, ABI-6250 remains an investigational product candidate, not yet approved anywhere globally, with its safety and efficacy still under evaluation.

Assembly Biosciences is committed to developing groundbreaking small-molecule antiviral therapeutics to alter the trajectory of severe viral diseases and enhance patient outcomes worldwide. Led by experienced leaders in virologic drug development, Assembly Bio focuses on improving the lives of patients affected by chronic conditions such as herpesvirus, hepatitis B virus (HBV), and hepatitis delta virus (HDV) infections.

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