Erik van den Berg, AM-Pharma CEO

AM-Phar­ma flies white flag on PhI­II bat­tle, but they aren't giv­ing up on their kid­ney drug

The Dutch biotech AM-Phar­ma lost the Phase III bat­tle on kid­ney dis­ease, but they’re still fight­ing the long reg­u­la­to­ry war.

The biotech put out word ear­ly Thurs­day that the team has shut­tered their Phase III tri­al for ilo­fo­tase al­fa that guards against kid­ney in­jury af­ter the treat­ment failed an in­ter­im analy­sis on the pri­ma­ry: 28-day all cause mor­tal­i­ty.

But they went on to an­a­lyze all the da­ta from pa­tients suf­fer­ing from sep­sis-as­so­ci­at­ed acute kid­ney in­jury and re­searchers claimed a sig­nif­i­cant re­sponse on a key sec­ondary for a re­duc­tion on Ma­jor Ad­verse Kid­ney Events by day 90 (MAKE90). Mak­ing that case may not be so easy, though.

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