J&J drops its op­tion on Proven­tion Bio drug af­ter tri­al fail­ure

Two months af­ter a mid-stage flop, J&J told Proven­tion Bio they weren’t go­ing to buy back a Crohn’s dis­ease drug.

J&J li­censed the mol­e­cule, PRV-6527, to their fel­low New Jer­seyans in 2017 along­side one oth­er drug. That deal in­clud­ed a nar­row win­dow in which the phar­ma gi­ant could buy back PRV-6527 for $50 mil­lion and sin­gle-dig­it sales roy­al­ties.

The win­dow opened up with the read­out from a 93-pa­tient Phase IIa tri­al in Oc­to­ber, af­ter which J&J had 90 days to ex­er­cise or de­cline the op­tion. Proven­tion tried to sal­vage the re­sults of the tri­al by fo­cus­ing on bio­mark­ers and “clin­i­cal­ly rel­e­vant ob­jec­tive end­points” such as hema­tol­ogy, but the drug failed to dif­fer­en­ti­ate it­self from place­bo on the pri­ma­ry end­point: Crohn’s Dis­ease Ac­tiv­i­ty In­dex score, a weight­ed sys­tem to as­sess dis­ease sever­i­ty.

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