Gosuranemab: another Alzheimer's candidate to bite the dust

Having scored a historic first last week, with accelerated US regulatory approval for the use of its Aduhelm (aducanumab) as the first treatment in nearly two decades to address an underlying cause of Alzheimer's disease, yesterday US biotech major Biogen (Nasdaq: BIIB) also added to the list of failures in the search for such treatments.

Biogen, whose shares dipped 1.2% to $391.31 on the news, reported top-line Phase II TANGO study results of gosuranemab (BIIB092), an investigational anti-tau antibody, that 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.