Press Release
Assembly Biosciences Initiates Phase 2 Trial Evaluating Second-Generation Core Inhibitor ABI-H2158 for Chronic Hepatitis B Infection
“We are excited to have three novel core inhibitors advancing in clinical development and to have our more potent second-generation candidate, 2158, now in a Phase 2 proof-of-concept study for chronic hepatitis B infection,” said
In the trial, 80 patients will be randomized three-to-one to receive either 300 mg oral 2158 plus entecavir or placebo plus entecavir once daily for up to 72 weeks. Primary endpoints include change in HBV DNA following 24 weeks of treatment, and safety and tolerability throughout the study. Other endpoints include changes in pgRNA and other viral antigens. Currently, initial sites are open for patient screening, with additional sites planned. Further details may be found at https://clinicaltrials.gov/ using identifier NCT04398134.
This proof-of-concept study builds on results from the recently completed Phase 1b dose-ranging study of 2158, where HBeAg-positive patients received doses of 2158 (100 mg, 300 mg, or 500 mg) or placebo once daily for 14 days. 2158 was well tolerated and demonstrated potent antiviral activity at the 300 mg dose. Clinical data from this trial have been selected as a late-breaker poster at the
About Assembly Biosciences’ HBV Core Inhibitor Portfolio
Assembly’s HBV portfolio includes three clinical-stage small molecules, all of which are HBV core protein inhibitors that target multiple steps of the HBV life cycle. In Phase 2 clinical trials, first-generation core inhibitor ABI-H0731 administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression compared to NrtI therapy alone, and has demonstrated significant declines in pgRNA that may indicate decreased cccDNA levels. Assembly’s HBV portfolio also includes two potent second-generation candidates, ABI-H2158 in a Phase 2 clinical trial and ABI-H3733 in Phase 1 development.
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 from those projected or implied. These risks and uncertainties include: Assembly’s ability to initiate and complete clinical trials involving ABI-H2158 in the currently anticipated timeframes; safety and efficacy data from ABI-H2158 may not warrant further development; clinical and nonclinical data may not differentiate Assembly’s product candidates from other companies’ candidates; and other risks identified from time to time in Assembly’s reports filed with the
ContactsAssembly Biosciences, Inc. Lauren Glaser Senior Vice President, Investor Relations and Corporate Affairs (415) 521-3828 lglaser@assemblybio.com
Source: Assembly Biosciences, Inc.