Assembly Biosciences Doses First Participant in Phase 1a Study of Oral HDV Entry Inhibitor ABI-6250

ASMB
October 04, 2025

Assembly Biosciences announced that the first participant has been dosed in the Phase 1a trial of ABI-6250, its orally bioavailable, small molecule hepatitis delta virus (HDV) entry inhibitor candidate. This study will evaluate the safety, tolerability, and pharmacokinetics of ABI-6250 across single and multiple ascending dose cohorts in healthy participants.

The Phase 1a study will also assess serum bile acids as a biomarker of ABI-6250’s engagement of its target, the sodium taurocholate cotransporting polypeptide (NTCP). Data from this Phase 1a study are expected in Q3 2025.

ABI-6250 has the potential to be the first oral therapy for chronic HDV, a life-threatening chronic viral infection with limited treatment options. Preclinical studies showed ABI-6250's low nanomolar potency across multiple HDV genotypes and a pharmacokinetic profile supporting once-daily oral dosing.

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