Jerry Durso, Intercept Pharmaceuticals CEO

By sum­mer sol­stice, we'll know the fate of In­ter­cep­t's NASH drug

In­ter­cept Phar­ma­ceu­ti­cals has an­oth­er date with the FDA, as the reg­u­la­tor will de­cide for a sec­ond time whether to ap­prove the biotech’s drug for pa­tients with pre-cir­rhot­ic liv­er fi­bro­sis due to non­al­co­holic steato­hep­ati­tis, or NASH.

The agency set an ac­tion date of June 22. FDA said no around the same time in 2020.

At stake is an ac­cel­er­at­ed ap­proval for obeti­cholic acid, or OCA, which is al­ready on the mar­ket for pri­ma­ry bil­iary cholan­gi­tis. In­ter­cept and ex-US rights own­er Ad­vanz mar­ket the drug as Ocali­va for the bile duct-de­stroy­ing dis­ease.

The drug de­vel­op­er tout­ed two in­ter­im analy­ses from the Phase III RE­GEN­ER­ATE study, which has brought mixed re­sults in the past four years. The once-dai­ly 25 mg group ex­pe­ri­enced a win on the pri­ma­ry end­point at an 18-month analy­sis, In­ter­cept said last Ju­ly, tout­ing 22.4% of pa­tients saw at least one stage of fi­bro­sis im­prove­ment with­out wors­en­ing of the fat­ty liv­er dis­ease. The place­bo group was 9.6%.

Pa­tients in the 10 mg group didn’t have the same ex­pe­ri­ence. That por­tion of the tri­al did not meet the pri­ma­ry end­point. On a sec­ond pri­ma­ry end­point, In­ter­cept said the drug didn’t meet the bar on res­o­lu­tion of NASH with no wors­en­ing of liv­er fi­bro­sis. At the time, Jef­feries an­a­lysts said it wasn’t a sur­prise.

Then, in Sep­tem­ber, In­ter­cept re­port­ed a fail on an­oth­er Phase III tri­al of the drug in NASH. The study, dubbed RE­VERSE, was not men­tioned in In­ter­cept’s Thurs­day morn­ing press re­lease an­nounc­ing the FDA’s ac­cep­tance of the NDA.

With safe­ty da­ta on near­ly 2,500 pa­tients, in­clud­ing 1,000 on the drug for four years, In­ter­cept con­tin­ues to think it can be the first to mar­ket with a NASH drug.

“This reg­u­la­to­ry mile­stone brings us one step clos­er to reach­ing our goal of de­liv­er­ing the first avail­able ther­a­py for pa­tients liv­ing with pre-cir­rhot­ic fi­bro­sis due to NASH – the most rapid­ly grow­ing cause of liv­er trans­plan­ta­tion in the U.S.,” Jer­ry Dur­so, CEO and pres­i­dent of In­ter­cept, said in a state­ment.

Bio­phar­mas have long been tripped up by R&D in NASH, but read­outs in re­cent months might paint a rosier pic­ture in the near fu­ture, with Madri­gal say­ing it will file for ac­cel­er­at­ed ap­proval ear­ly this year af­ter a Phase III win that sent shares sky­rock­et­ing and led to a $300 mil­lion cap­i­tal in­fu­sion. Akero Ther­a­peu­tics al­so buoyed the NASH field with wins on pri­ma­ry and mul­ti­ple sec­ondary goals in its Phase IIb study last fall. Mean­while, Chemomab Ther­a­peu­tics said it cleared a mid-stage test but doesn’t have im­me­di­ate plans to stay in NASH be­cause of the costs as­so­ci­at­ed with Phase III stud­ies in the space.

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