In­ter­cept ‘low­ers the bar’ on its piv­otal PhI­II OCA study for NASH

In­ter­cept CEO Mark Pruzan­s­ki has re­drawn the rules on their piv­otal Phase III study of obeti­cholic acid (OCA).

Af­ter talks with the FDA, Pruzan­s­ki said to­day that in­ves­ti­ga­tors can re­duce their tar­get on the num­ber of pa­tients need­ed for an in­ter­im analy­sis of the FXR ag­o­nist in 2019, drop­ping the tar­get from 1,400 to 750. And the agency has signed off on chang­ing the end­point from fi­bro­sis and NASH res­o­lu­tion to ei­ther fi­bro­sis or NASH while ac­cept­ing an ob­jec­tive de­f­i­n­i­tion of NASH res­o­lu­tion to clar­i­fy suc­cess.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA