“We are excited to share the latest data on our promising HDV/HBV entry inhibitor program and next-generation HBV core inhibitors with the scientific community,” said
HBV/HDV Entry Inhibitor Program
HDV is a satellite virus only found in the presence of HBV, and HDV/HBV co-infection is considered the most severe form of chronic viral hepatitis due to faster liver disease progression. A poster entitled “A novel class of orally available small molecules potently inhibit hepatitis B and D virus entry” presents insights on the identification of a novel class of highly potent, orally bioavailable HBV/HDV entry inhibitors which show nanomolar (nM) potency, metabolic stability and good oral bioavailability. These inhibitors interfere with preS1 protein binding and NTCP-mediated bile acid uptake, reinforcing that the molecular target is NTCP (sodium taurocholate co-transporting polypeptide, a protein exclusively expressed on the membrane of hepatocytes). Assembly Bio anticipates the nomination of a development candidate this year.
Next-Generation HBV Core Inhibitor Candidates ABI-H3733 and ABI-4334
ABI-H3733 (3733) and ABI-4334 (4334) are novel, structurally distinct, orally bioavailable investigational core inhibitors that exhibit nM potency against pgRNA encapsidation and covalently closed circular (ccc)DNA formation.
The poster entitled “The safety and pharmacokinetics of ABI-4334, a novel next-generation HBV core inhibitor: interim results from a Phase 1 study in healthy volunteers” showcases data from a single (SAD) and multiple ascending dose (MAD) first-in-human study in healthy volunteers. The therapy was well tolerated when administered orally up to 400 mg as a single dose or up to 200 mg once a day for eight days, with no Grade 3 or 4 adverse events (AEs), serious AEs or deaths. Potential for best-in-class activity is projected, with a once daily dose of 200 mg estimated to achieve 175× the predicted plasma adjusted (pa) EC50 values for viral replication inhibition and 34× paEC50 for the prevention of cccDNA formation.
The poster entitled “Safety, pharmacokinetics, and antiviral activity of the next-generation hepatitis B core inhibitor ABI-H3733 in patients with hepatitis B e antigen negative chronic hepatitis B infection: preliminary results from a randomized, blinded, Phase 1b study” has been selected for inclusion in the viral hepatitis track hub and to be featured in the Best of
In vitro data presented in the poster entitled “Next generation core inhibitors ABI-H3733 and ABI-4334 have significantly improved potency and target coverage for both antiviral and cccDNA formation activities compared to first-generation core inhibitors” show that 3733 and 4334 are significantly more potent in preventing viral replication and cccDNA formation compared to the first-generation core inhibitor, vebicorvir (VBR). Additionally, these data show that 3733 and 4334 have significantly improved human exposure coverage for both viral replication and cccDNA formation as compared with VBR.
Vebicorvir (VBR) Phase 2 Combination Data
The first-generation core inhibitor candidate, VBR, was evaluated in a Phase 2 study in combination with entecavir (ETV) and pegylated interferon alpha (Peg-IFNα) in patients with hepatitis B e antigen positive cHBV infection. Highlighted in a poster entitled “Vebicorvir, entecavir, and pegylated interferon in patients with hepatitis B e antigen positive chronic hepatitis B virus infection: findings from a Phase 2, randomized open-label study in
Subsequent to presentation at EASL’s International Liver Congress™ 2023, Assembly Bio intends to make the posters available on the “Events & Presentations” page in the “Investors” section of its website at www.assemblybio.com.
About Assembly Biosciences
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 maintain financial resources necessary to continue its clinical studies and fund business operations; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; 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
Contacts
Investor and Corporate:
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
sryan@assemblybio.com
Media:
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