In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

In­ter­cept Phar­ma­ceu­ti­cals has run in­to an­oth­er big set­back in its years­long quest to win an ap­proval for OCA in NASH. The biotech put out word Fri­day morn­ing that its Phase III RE­VERSE study failed the pri­ma­ry end­point for the liv­er dis­ease, send­ing its share price in­to a tail­spin.

There was no sig­nif­i­cant im­prove­ment in fi­bro­sis among the pa­tients suf­fer­ing from cir­rho­sis who were treat­ed with obeti­cholic acid, with in­ves­ti­ga­tors hunt­ing for a min­i­mum 1-stage his­to­log­i­cal im­prove­ment in the dis­ease af­ter 18 months of ther­a­py.

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