ABI-6250 / Assembly Biosci, Gilead - LARVOL DELTA

A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Assembly Biosciences

New P2 trial • Infectious Disease • Inflammation

Safety, pharmacokinetics, and pharmacodynamic activity of ABI-6250, a first in class oral hepatitis D virus entry inhibitor in healthy subjects: interim results from a randomized, blinded, phase 1a study (EASL 2026) - P1 | "Bulevirtide (BLV), an inhibitor of the sodium-taurocholate co- transporting polypeptide (NTCP), has been approved for the treatment of HDV infection in some countries. Overall, 6250 was well tolerated when administered as single doses up to 25mg, and up to 1mg QD for 10 days. Dose dependent elevations in plasma BAs were observed. Planning for a longer duration Phase 2 study in subjects with chronic HDV infection is ongoing."

Clinical • P1 data • PK/PD data • Hepatology • Infectious Disease • Inflammation

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Assembly Biosciences | Recruiting ➔ Completed | N=78 ➔ 40

Enrollment change • Trial completion • Inflammation

Preclinical profiling of ABI-6250, a first-in-class oral therapeutic candidate for chronic hepatitis (EASL 2025) - "Bulevirtide (BLV), an injectable peptide inhibiting HDV entry via binding to the sodium taurocholate co-transporting peptide (NTCP) receptor (a bile acid [BA] transporter) is approved in Europe for the treatment of cHDV. ABI-6250, a highly potent and selective orally bioavail- able first-in-class HDV entry inhibitor, has demonstrated promising preclinical results. ABI-6250 elevates total BAs in monkeys at projected clinically-relevant concentrations without raising CP-I plasma levels, indicating selective NTCP target engagement. ABI- 6250's preclinical PK profile supports once-daily oral dosing for cHDV treatment, and a Phase 1a clinical trial is currently ongoing."

Late-breaking abstract • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Respiratory Syncytial Virus Infections • ABCB1 • SLC22A1

Assembly Biosciences Doses First Participant in Phase 1a Clinical Study of Oral Entry Inhibitor Candidate ABI-6250 for Hepatitis Delta Virus (GlobeNewswire) - "Assembly Biosciences, Inc...today announced that the first participant has been dosed in the Phase 1a trial of ABI-6250, the company’s orally bioavailable, small molecule hepatitis delta virus (HDV) entry inhibitor candidate...Assembly Bio expects to share data from the Phase 1a study in Q3 2025."

P1 data • Trial status • Infectious Disease

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Assembly Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Inflammation

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Assembly Biosciences

New P1 trial • Hepatology • Inflammation

Preclinical profiling of ABI-6250, a novel orally bioavailable small-molecule therapeutic candidate for the treatment of chronic hepatitis D (EASL-ILC 2024) - "Bulevirtide (BLV), a peptide preventing the binding of HDV to sodium taurocholate co- transporting polypeptide (NTCP), the viral entry receptor, is approved in Europe for the treatment of cHDV. ABI-6250 is a highly potent, orally bioavailable HDV entry inhibitor with a preclinical profile supporting a once-daily oral therapy for cHDV and is expected to enter Phase 1 clinical studies by the end of 2024."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation