Roche to end DIAN-TU-001 study for rare Autosomnal dominant Alzheimer's disease

10 February 2020 – Roche‌ ‌announced‌ ‌today‌ ‌that‌ ‌it‌ ‌has‌ ‌ended‌ ‌the‌ ‌gantenerumab‌ ‌arm‌ ‌of‌ ‌the‌ ‌Phase‌ ‌II/III‌ ‌DIAN-TU-001‌ ‌study‌ ‌after‌ ‌it‌ ‌failed‌ ‌to‌ ‌meets‌ ‌its‌ ‌primary‌ ‌endpoint‌ ‌in‌ ‌people‌ ‌who‌ ‌are‌ ‌affected‌ ‌by‌ ‌early‌ ‌onset‌ ‌Autosomal‌ ‌dominant‌ ‌Alzheimer’s‌ ‌disease.‌ ‌

Autosomal‌ ‌dominant‌ ‌AD‌ ‌is‌ ‌a‌ ‌rare,‌ ‌inherited‌ ‌form‌ ‌of‌ ‌Alzheimer’s‌ ‌disease,‌ ‌which‌ ‌accounts‌ ‌for‌ ‌less‌ ‌than‌ ‌1%‌ ‌of‌ ‌all‌ ‌Alzheimer’s‌ ‌related‌ ‌disease‌ ‌globally.‌ ‌

Spearheaded‌ ‌by‌ ‌Washington‌ ‌University‌ ‌School‌ ‌of‌ ‌Medicine‌ ‌in‌ ‌St.‌ ‌Louis,‌ ‌US,‌ ‌the‌ ‌DIAN-TU-001‌ ‌is‌ ‌a‌ ‌Phase‌ ‌II/III‌ ‌study‌ ‌which‌ ‌tested‌ ‌two‌ ‌investigational‌ ‌therapies‌ ‌against‌ ‌placebo,‌ ‌to‌ ‌see‌ ‌if‌ ‌either‌ ‌of‌ ‌the‌ ‌two‌ ‌therapies‌ ‌could‌ ‌slow‌ ‌the‌ ‌rate‌ ‌of‌ ‌cognitive‌ ‌decline,‌ ‌as‌ ‌well‌ ‌as‌ ‌improve‌ ‌the‌ ‌biomarkers‌ ‌in‌ ‌people‌ ‌who‌ ‌are‌ ‌known‌ ‌to‌ ‌have‌ ‌a‌ ‌genetic‌ ‌mutation‌ ‌for‌ ‌inherited‌ ‌Alzheimer’s‌ ‌disease.‌ ‌The‌ ‌two‌ ‌investigational‌ ‌therapies‌ ‌tested‌ ‌were‌ ‌Roche’s‌ ‌gantenerumab‌ ‌and‌ ‌Eli‌ ‌Lilly’s‌ ‌solanenezum.‌ ‌

Gantenerumab‌ ‌will‌ ‌continue‌ ‌to‌ ‌be‌ ‌studied‌ ‌in‌ ‌two‌ ‌large‌ ‌global‌ ‌Phase‌ ‌III‌ ‌studies,‌ ‌which‌ ‌looks‌ ‌at‌ ‌the‌ ‌general‌ ‌population‌ ‌of‌ ‌people‌ ‌who‌ ‌have‌ ‌Alzheimer’s‌ ‌disease‌ ‌that‌ ‌has‌ ‌not‌ ‌directly‌ ‌been‌ ‌caused‌ ‌by‌ ‌genetic‌ ‌mutations.‌ ‌

Additional‌ ‌analyses‌ ‌in‌ ‌understanding‌ ‌the‌ ‌totality‌ ‌of‌ ‌gantenerumab‌ ‌within‌ ‌the‌ ‌DIAN-TU-001‌ ‌study‌ ‌are‌ ‌being‌ ‌conducted‌ ‌by‌ ‌Roche‌ ‌with‌ ‌the‌ ‌University‌ ‌of‌ ‌Washington,‌ ‌and‌ ‌will‌ ‌be‌ ‌presented‌ ‌at‌ ‌the‌ ‌AAT-AD/PD‌ ‌Focus‌ ‌meeting‌ ‌in‌ ‌April‌ ‌2020.‌ ‌

Levi‌ ‌Garraway,‌ ‌M.D.,‌ ‌Ph.D.,‌ ‌Chief‌ ‌Medical‌ ‌Officer‌ ‌and‌ ‌Head‌ ‌of‌ ‌Global‌ ‌Product‌ ‌Development‌ ‌of‌ ‌Roche,‌ ‌said‌ ‌in‌ ‌the press release:  ‌‌“We‌ ‌are‌ ‌very‌ ‌grateful‌ ‌to‌ ‌all‌ ‌those‌ ‌involved‌ ‌in‌ ‌this‌ ‌study‌ ‌and‌ ‌hope‌ ‌the‌ ‌data‌ ‌can‌ ‌further‌ ‌contribute‌ ‌to‌ ‌the‌ ‌science‌ ‌and‌ ‌collective‌ ‌understanding‌ ‌of‌ ‌this‌ ‌complex‌ ‌disease.”‌ ‌ ‌

Despite‌ ‌the‌ ‌ending‌ ‌of‌ ‌the‌ ‌DIAN-TU-001‌ ‌study,‌ ‌ADI‌ ‌remains‌ ‌confident‌ ‌in‌ ‌Roche’s‌ ‌commitment‌ ‌to‌ ‌the‌ ‌research‌ ‌into‌ ‌treatment‌ ‌for‌ ‌Alzheimer’s‌ ‌disease‌ ‌and‌ ‌other‌ ‌neurological‌ ‌conditions.‌ ‌

Paola‌ ‌Barbarino,‌ ‌Chief‌ ‌Executive‌ ‌of‌ ‌ADI‌ ‌said:‌ ‌‌“‌It‌ ‌is‌ ‌of‌ ‌course‌ ‌disappointing‌ ‌to‌ ‌see‌ ‌such‌ ‌a‌ ‌promising‌ ‌study‌ ‌in‌ ‌such‌ ‌an‌ ‌interesting‌ ‌field‌ ‌to‌ ‌come‌ ‌to‌ ‌an‌ ‌end.‌ ‌My‌ ‌heart‌ ‌goes‌ ‌out‌ ‌to‌ ‌all‌ ‌those‌ ‌researchers‌ ‌who‌ ‌have‌ ‌worked‌ ‌so‌ ‌hard‌ ‌on‌ ‌the‌ ‌project.‌ ‌Nevertheless‌ ‌it‌ ‌is‌ ‌important‌ ‌to‌ ‌remember‌ ‌that‌ ‌Roche‌ ‌is‌ ‌working‌ ‌on‌ ‌other‌ ‌important‌ ‌breakthroughs‌ ‌and‌ ‌that‌ ‌their‌ ‌commitment‌ ‌to‌ ‌those‌ ‌is‌ ‌unchanged.‌ ‌We‌ ‌thank‌ ‌all‌ ‌at‌ ‌Roche‌ ‌for‌ ‌continuing‌ ‌to‌ ‌keep‌ ‌our‌ ‌hopes‌ ‌up‌.”‌ ‌

To‌ ‌find‌ ‌out‌ ‌more,‌ ‌read‌ ‌Roche’s‌ ‌press‌ ‌release.‌ ‌