As­sem­bly Bio ditch­es he­pati­tis B drug on liv­er tox­i­c­i­ty con­cerns in mid-stage test

Bay Area mi­cro­cap biotech As­sem­bly Bio had big plans for a lead he­pati­tis B drug, but safe­ty red flags have now led the com­pa­ny to ditch the pro­gram al­to­geth­er.

As­sem­bly Bio has dis­con­tin­ued de­vel­op­ment of ABI-H2158, its can­di­date to treat he­pati­tis B, af­ter ob­serv­ing el­e­vat­ed lev­els of ala­nine transam­i­nase (ALT) — a sign of liv­er tox­i­c­i­ty — in Phase II pa­tients, the biotech said Wednes­day.

The Phase II tri­al test­ed ABI-H2158 in 88 treat­ment-naïve pa­tients with HBeAg pos­i­tive or HBeAg neg­a­tive chron­ic he­pati­tis B in­fec­tion with­out cir­rho­sis, with pa­tients ran­dom­ized to re­ceive ei­ther a 300 mg dose of 2158 plus en­te­cavir or place­bo plus en­te­cavir once dai­ly for up to 72 weeks.

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