Topline results from phase II study of gosuranemab, an anti-Tau antibody, for Alzheimer’s disease. Biogen.

Gosuranemab did not meet its primary efficacy endpoint of change from baseline at week 78 on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) compared to placebo in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia. No treatment benefit was seen on exploratory efficacy endpoints, including the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer Disease Cooperative Study Activity of Daily Living (ADCS-ADL), the Mini-Mental State Examination (MMSE) and the Functional Assessment Questionnaire (FAQ). Gosuranemab was well-tolerated overall, and safety outcomes were consistent with previous studies of the molecule.

Gosuranemab is an antibody directed against the N-terminus of tau. Target engagement was demonstrated with lowering of N-terminal tau in cerebrospinal fluid (CSF), consistent with prior studies. However, in the TANGO Study, no statistically significant treatment effect was observed on tau-PET at week 78 for any of the dose groups.

Based on these results, the TANGO study has been terminated. Biogen will discontinue clinical development of gosuranemab. Analyses of additional data, including CSF biomarkers, are ongoing, and Biogen plans to present these TANGO results at an upcoming medical congress.