ABI-6250 / Assembly Biosci - LARVOL DELTA

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