Biogen Announces Topline Results From Phase 2 Study of Gosuranemab, an Anti-Tau Antibody, for Alzheimer’s Disease
CAMBRIDGE, Mass., June 16, 2021 (GLOBE NEWSWIRE) -- (Nasdaq: BIIB) today announced topline results from its Phase 2 TANGO study of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer’s disease.
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.
“While we are disappointed by the results of the Phase 2 study of gosuranemab, we know that the path to innovation is not a straight line, and that we always learn from each trial. We are investing in a broad neuroscience pipeline, including other tau approaches for Alzheimer’s disease,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. “We extend our deepest gratitude to the participants, site staff and the broader Alzheimer’s disease community who contributed to the TANGO study.”
Based on these results, the TANGO study has been terminated. Biogen will discontinue clinical development of gosuranemab.