Monopar puts a stop to its chemo com­pli­ca­tion drug; Ex­i­cure ex­plores fu­ture trans­ac­tions

The biotech Monopar Ther­a­peu­tics is putting a ki­bosh on a study for its drug to pre­vent se­vere oral mu­cosi­tis (SOM) in pa­tients who are go­ing through chemora­dio­ther­a­py for oropha­ryn­geal can­cer.

The in­ter­im analy­sis for Monopar’s Phase IIb/III had around 50% of the planned pa­tients en­rolled. An in­de­pen­dent da­ta safe­ty mon­i­tor­ing board let Monopar know that the tri­al did not meet the thresh­old for ef­fi­ca­cy. The tri­al was look­ing for a 15% of ab­solute dif­fer­ence in SOM pre­ven­tion be­tween its drug, Va­lidive, and place­bo. Monopar will now dis­con­tin­ue the study as well as the de­vel­op­ment of Va­lidive.

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