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Assembly Bio discontinues development of hepatitis drug ABI-H2158

The company intends to focus on development of other hepatitis drug candidates.

By Brian Buntz | September 1, 2021

https://www.google.com/search?q=Assembly+Biosciences&client=safari&rls=en&source=lnms&tbm=isch&sa=X&ved=2ahUKEwiLko-51N7yAhUhJTQIHfuNC4YQ_AUoA3oECAEQBQ&biw=1440&bih=751#imgrc=nabIo_jo5ghK5MAssembly Biosciences (NSDQ:ASMB) is halting the development of the hepatitis drug ABI-H2158 (2158) after observing elevated alanine aminotransferase (ALT) in participants in a Phase 2 trial.

High ALT levels can indicate liver damage.

“Patient safety is always our priority, which is why we have elected to discontinue the development of 2158,” said Dr. John McHutchison, chief executive officer and president of Assembly Bio, in a statement.

The company intends to focus on another investigational drug for hepatitis B from its portfolio and “ultimately choose the best and safest candidate to take forward into later-stage clinical trials,” McHutchison explained.

The company notes that its capsid inhibitor vebicorvir (VBR/ABI-H0731), has demonstrated safety and efficacy in patients for up to 1.5 years in a Phase 2 clinical trial.

Last month, Assembly Biosciences announced that it chose the core inhibitor candidate, ABI-4334 (4334), to proceed into clinical development.

In February, the company announced that it would launch a Phase 2 clinical trial of vebicorvir (VBR) in combination with the GalNAc delivered RNAi therapeutic candidate, AB-729 from Arbutus Biopharma (Vancouver). That trial will provide the combination treatment in conjunction with standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy.


Filed Under: clinical trials, Drug Discovery, Gastroenterology
Tagged With: 4334, AB-729, ABI-4334, ABI-H2158, alanine aminotransferase, Assembly Biosciences, hepatitis B, VBR/ABI-H0731
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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