Norbert Bischofberger (Kronos)

Kro­nos seals pact with reg­u­la­tors to hunt AML with pre­vi­ous­ly off-lim­its bio­mark­er end­point

As head of R&D at Gilead, Nor­bert Bischof­berg­er shelved the SYK in­hibitor en­tosple­tinib af­ter it proved to need too lengthy a de­vel­op­ment cy­cle to win ap­proval. The FDA heard those con­cerns and will now give en­tosple­tinib, once again un­der Bischof­berg­er’s watch­ful eye at Kro­nos, a faster shot on goal.

Kro­nos has reached an agree­ment with the FDA to con­duct a Phase III tri­al with a unique pri­ma­ry end­point, the com­pa­ny an­nounced Thurs­day, one that it hopes will ac­cel­er­ate en­tosple­tinib’s path for­ward in a cer­tain type of acute myeloid leukemia. The end­point is mea­sur­able resid­ual dis­ease (MRD) neg­a­tiv­i­ty, which Kro­nos says can paint a clear­er pic­ture when it comes to the study’s com­plete re­sponse rate.

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