‘Inferior efficacy’ leads to premature end of PhIII for Bayer’s next-gen blood thinner asundexian

Bay­er is bring­ing a Phase III tri­al for its blood thin­ner asun­dex­i­an to an ear­ly end af­ter the drug showed “in­fe­ri­or ef­fi­ca­cy” against the con­trol arm, the com­pa­ny an­nounced Sun­day.

OCEAN­IC-AF is the first of three large Phase III stud­ies Bay­er has planned for asun­dex­i­an, a top late-stage can­di­date that ex­ec­u­tives said they “con­tin­ue to feel very strong about” as re­cent­ly as the third-quar­ter earn­ings call. It was de­signed to com­pare asun­dex­i­an with Eliquis, or apix­a­ban, a long­stand­ing an­ti­co­ag­u­lant, in 18,000 pa­tients with atri­al fib­ril­la­tion (AF) at risk for stroke. It was orig­i­nal­ly set to con­clude in the sum­mer of 2025, per a clin­i­cal­tri­als.gov list­ing.

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