Biogen IncPhase II data showed lack of dose-dependent efficacy, raising doubts about diranersen's advancement to Phase III.
Biogen shares fell 8.2% after the company presented detailed phase II CELIA study data for its experimental tau-targeting Alzheimer's drug diranersen at the Alzheimer's Association International Conference. The data confirmed the trial did not meet its primary endpoint of demonstrating a dose-response relationship on the Clinical Dementia Rating–Sum of Boxes score, as higher doses did not produce greater clinical benefit. The lowest 60 mg dose showed a 26% slowing of cognitive decline on that scale, while the two 115 mg regimens showed only 14% and 9% slowing, respectively. Investors appeared concerned about Biogen's plans to advance diranersen into confirmatory phase III development given the lack of dose-dependent efficacy. Biogen has not disclosed a timeline for late-stage development of the drug, which it is developing with Ionis Pharmaceuticals.
Biogen IncPhase II data showed lack of dose-dependent efficacy, raising doubts about diranersen's advancement to Phase III.
Ionis Pharmaceuticals IncAs co-developer of diranersen, the negative trial data impacts Ionis's pipeline prospects.
Eli Lilly and Company