Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cy­to­ki­net­ics’ heart drug tech­ni­cal­ly met its pri­ma­ry end­point back in No­vem­ber, it missed a key sec­ondary end­point — re­duc­tion in car­dio­vas­cu­lar death — which even­tu­al­ly cost the com­pa­ny two part­ner­ships. Now the team is back with da­ta sug­gest­ing the drug works bet­ter in sick­er pa­tients, and it’s plan­ning a trip to the FDA.

In a post-hoc analy­sis, which can be a very dif­fi­cult sale at the FDA, Cy­to­ki­net­ics sep­a­rat­ed pa­tients from the Phase III GALAC­TIC-HF study in­to four quar­tiles based on ejec­tion frac­tion, a mea­sure­ment of how well the left ven­tri­cle pumps blood with each heart­beat. Pa­tients in the low­er two quar­tiles — those with an EF of 22% or low­er, and be­tween 29% to 32% — saw a 15% and 17% rel­a­tive risk re­duc­tion of heart fail­ure events and car­dio­vas­cu­lar death com­bined, Cy­to­ki­net­ics re­port­ed at ACC. No dif­fer­ence was seen in the up­per two quar­tiles.

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