NASH, the no­to­ri­ous liv­er dis­ease af­flict­ing an in­creas­ing num­ber of Amer­i­cans, has al­ways been the fo­cus at Metacrine ever since se­r­i­al en­tre­pre­neur Rich Hey­man un­veiled the first round of fi­nanc­ing all the way back in 2015.

Not any­more.

The San Diego-based biotech is halt­ing its NASH pro­gram and choos­ing in­stead to pri­or­i­tize its ef­fort in push­ing the same FXR ag­o­nist, MET642, in­to a Phase II tri­al for in­flam­ma­to­ry bow­el dis­ease.

Metacrine joins a long line of biotechs tak­ing a step back from NASH. Just this year, NGM and Enan­ta have shift­ed fo­cus in the wake of tri­al flops; and that’s fol­low­ing set­backs at Gen­fit, In­ter­cept, CymaBay and Al­bireo.

Ac­cord­ing to Metacrine, pre­lim­i­nary re­sults from a nine-month an­i­mal tox­i­col­o­gy study have flagged the need for a re­view — which will de­ter­mine whether it needs an­oth­er long-term an­i­mal tox­i­col­o­gy study be­fore start­ing Phase III in IBD.

Even though Metacrine called an in­ter­im read­out from a 16-week Phase IIa tri­al pos­i­tive, CEO Pre­ston Klassen sug­gest­ed it’s not worth the “sig­nif­i­cant cap­i­tal and re­sources re­quired” to move in­to a large late-stage tri­al at this time.

“This de­ci­sion was in­flu­enced in part by a po­ten­tial de­lay in con­firm­ing ap­pro­pri­ate safe­ty mar­gins in our long-term tox­i­col­o­gy work that would im­pact the tim­ing of fu­ture NASH stud­ies, but is un­like­ly to im­pact time­lines for the IBD clin­i­cal pro­gram,” he said.

FXR-based ther­a­pies, he added, hold great promise in IBD be­cause of their role in in­testi­nal func­tion. Plus, un­like oth­er ther­a­pies for the dis­ease, it doesn’t come with im­muno­sup­pres­sion.

Still, Metacrine isn’t en­tire­ly giv­ing up on NASH. A 3mg dose of MET642 demon­strat­ed “mean­ing­ful liv­er fat re­duc­tion” and a de­cent tol­er­a­bil­i­ty pro­file — al­though the high­er dose pre­sent­ed a murki­er pic­ture.

The be­lief now, echo­ing the strat­e­gy be­ing pur­sued at bat­tle-test­ed Gilead and No­vo Nordisk, is that treat­ing NASH will like­ly re­quire com­bi­na­tion regimes, Klassen not­ed, of which MET642 can be a part.

“In this small in­ter­im analy­sis, the 6 mg co­hort dis­played a non-nor­mal dis­tri­b­u­tion in liv­er fat changes, as ev­i­denced by dif­fer­ences be­tween the mean and me­di­an re­sults,” he said. “Fur­ther clar­i­fi­ca­tion of the im­pact on liv­er fat at the 6 mg dose will re­quire ex­am­i­na­tion of the com­plete tri­al da­ta set, which is an­tic­i­pat­ed in the first half of 2022.”

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.