Look­ing for an ear­ly suc­cess in PhII Alzheimer’s study, Bio­gen and Ei­sai just racked up the lat­est set­back

Chalk up an­oth­er big set­back for the amy­loid be­ta the­o­ry and an­oth­er failed at­tempt at blaz­ing a clin­i­cal path to suc­cess.

In­ves­ti­ga­tors for Bio­gen $BI­IB and Ei­sai say that their an­ti-amy­loid be­ta an­ti­body BAN2401 flunked the 12-month pri­ma­ry end­point in their Phase II study. They had hoped that us­ing Bayesian analy­sis meth­ods would set them up for an ear­ly win, based on a new goal for suc­cess us­ing a com­pos­ite dis­ease score with the pa­tients en­rolled. Now they will go on to the full 18 month mark and then run a check of bio­mark­ers for the dis­ease — which has proven to be a re­mark­ably un­re­li­able as­sess­ment for clin­i­cal ef­fi­ca­cy.

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