Boehringer em­barks on a PhI­II odyssey for a failed Alzheimer's drug — now re­fo­cused on schiz­o­phre­nia with new tri­al tech and a ‘break­through’ at the FDA

In the 8 months since re­searchers at Boehringer In­gel­heim laid claim to a Phase II win for their schiz­o­phre­nia drug BI 425809, the project team has been busi­ly work­ing up an am­bi­tious Phase III pro­gram.

They’ve now laid out plans for a se­ries of 3 late-stage stud­ies aimed at prov­ing be­yond doubt that the drug can go on to be­come the first to be ap­proved for treat­ing the im­pair­ment of cog­ni­tive func­tion among schiz­o­phre­nia pa­tients. They have plans to in­cor­po­rate some new tech to flesh out their end­points. And now the FDA is jump­ing aboard with a break­through ther­a­py des­ig­na­tion to see if they can help speed the way through the clin­ic to a clear out­come.

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