Quote: 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.
-- *ENTA (#msg-153696410) and ASMB (#msg-148672065) are also developing an HBV capsid inhibitor (a/k/a “core” inhibitor or CpAM).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”