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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