On 16 June, the global biotechnology company Biogen announced topline results from its Phase II study of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer’s disease (AD). The TANGO Phase II trial was a 78-week double-blind, placebo-controlled and parallel-group study evaluating the safety and efficacy of gosuranemab in people with mild cognitive impairment (MCI) due to AD or with mild AD. A total of 654 participants (50-80 years old) received gosuranemab or placebo once every 4 weeks across 97 sites in US and Europe.
To-line results showed that the study did not meet its primary endpoint, which was a change on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB). Although gosuranemab was well-tolerated overall, 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). Based on these topline results, the TANGO study has been terminated. Analyses of additional data are ongoing and the company plans to present the findings at upcoming events.