Benzinga | Jun 9, 2021 08:08AM EDT

Assembly Biosciences To Present Data From HBV Core Inhibitor Programs At The International Liver Congress EASL 2021

Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today announced that three abstracts have been accepted for presentation during the International Liver Congress(tm) 2021, the Annual Meeting of the European Association for the Study of the Liver (EASL) taking place virtually June 23-26, 2021. During the meeting, data from Assembly Bio's three core inhibitor programs, vebicorvir (VBR), ABI-H2158 (2158) and ABI-H3733 (3733), will be featured in an oral presentation and two poster presentations.

"We're pleased to join our esteemed colleagues on the global stage that EASL affords to present data on our next-generation core inhibitors, 2158 and 3733, and to share further learnings from previous studies of VBR, which we are advancing in two proof-of-concept multi-drug combination studies for the treatment of chronic hepatitis B infection," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio.

Presentation Details

Posters are expected to be made available to conference registrants through the online EASL portal at the start of the meeting on the morning of Wednesday, June 23, 2021. The posters and oral presentation will be available subsequently on the "Events & Presentations" page in the "Investors" section of Assembly Bio's website at www.assemblybio.com

Oral Presentation OS-2299: Second generation hepatitis B virus core inhibitors ABI-H2158 and ABI-H3733 have enhanced potency and target coverage for both antiviral inhibition and covalently closed circular DNA establishment activities

Session: Hepatitis B: Novel therapeutic approaches

Date: June 25 at 3:00 -- 3:15 p.m. CET

Presenter: William Delaney, PhD, Chief Scientific Officer, Assembly Bio

Summary VBR, 2158, and 3733 achieve plasma concentrations significantly above EC50 and protein-adjusted EC50 for antiviral activity. The next-generation compounds 2158 and 3733 show enhanced potency and exposures that cover cccDNA prevention at significant multiples above protein-adjusted EC50 at Cmin.

Poster PO-1286: No emergent core inhibitor resistance in patients with chronic hepatitis B virus infection treated with vebicorvir in combination with a nucleos(t)ide reverse transcriptase inhibitor

Session: Viral hepatitis B/D: Therapy

Date: June 23 at 8:00 a.m. CET

Presenter: Man-Fung Yuen MD, PhD, Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong

Summary Sequence analyses were conducted for virologically-suppressed patients with chronic HBV enrolled in the Phase 2 Study 201 and open-label extension Study 211 of VBR in combination with a nucleos(t)ide reverse transcriptase inhibitor (NrtI) who discontinued treatment. Overall, most patients (78%) did not have detectable core inhibitor substitutions; for patients harboring a core inhibitor substitution (22%), no enrichment compared to baseline was observed after treatment was removed.

Poster PO-482: Viral response and safety following discontinuation of treatment with the core inhibitor vebicorvir and a nucleos(t)ide reverse transcriptase inhibitor in patients with HBeAg positive or negative chronic hepatitis B virus infection

Session:Viral hepatitis B/D: Therapy

Date:June 23 at 8:00 a.m. CET

Presenter:Edward Gane, MBChB, MD FRACP, MNZM, New Zealand Liver Transplant Unit, Auckland City Hospital, New Zealand

Summary: In the Phase 2 Study 201 and open-label extension Study 211, VBR+NrtI resulted in deep on-treatment virologic suppression. Stopping criteria were applied and eligible patients discontinued both VBR+NrtI. Discontinuation of VBR+NrtI treatment was well-tolerated, but sustained virologic response was not achieved. Further data analyses suggest core-related antigen level may be important in future discontinuation criteria. Other studies with VBR+NrtI in multi-drug combinations will evaluate potential finite treatment regimens.