Biotech Values

[DewDiligence]

ABUS kills another HBV compound—AB-452, an oral RNA destabilizer—due to safety problem:

https://www.globenewswire.com/news-release/2020/02/10/1982301/0/en/Arbutus-Announces-Decision-to-Discontinue-AB-452-and-to-Pursue-Development-of-a-Next-Generation-HBV-Specific-Oral-RNA-Destabilizer.html

In October 2018, Arbutus announced its decision to delay the initiation of a planned 28-day Phase 1a/1b clinical trial for AB-452 in order to further evaluate the safety of the compound. This decision was based on findings in 90-day preclinical safety studies in two species. Since that time Arbutus has extensively reviewed and further characterized these preclinical findings, including repeating the 90-day safety studies.

Michael J. Sofia, Ph.D., Chief Scientific Officer of Arbutus, added, “After reviewing all the data from the preclinical studies, and in consultation with external regulatory and pre-clinical experts, we have decided to not move AB-452 forward.

This is second HBV compound ABUS has killed off in the past few months—in Oct 2019 ABUS terminated AB-506, a capsid inhibitor, due to a safety problem (#msg-151513575).

What’s left in ABUS’ pipeline? ABS-729, an injected RNA destabilizer, is in phase-1; and ABS-836 (the successor to the terminated AB-506), a capsid inhibitor*, is in preclinical development with phase-1 anticipated in 2021.

ABUS is down “only” 6% on today’s PR because it has been known for over a year that AB-452 had a safety issue.

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*ENTA (#msg-153696410) and ASMB (#msg-148672065) are also developing an HBV capsid inhibitor (a/k/a “core” inhibitor or CpAM).