Biogen has discontinued clinical development of its anti-tau antibody gosuranemab after the drug failed to meet the primary endpoint in a phase 2 study.
The TANGO study was designed to evaluate the efficacy of gosuranemab in slowing rates of clinical progression in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease.
However, the anti-tau antibody failed to meet the primary endpoint of change from baseline at week 78 on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) compared to placebo in this patient population.
The study also found no treatment benefit 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).
“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,” said Alfred Sandrock, head of research and development at Biogen.
“We are investing in a broad neuroscience pipeline, including other tau approaches for Alzheimer’s disease,” he added.
Gosuranemab is designed to target the N-terminus of tau, an emerging target for drug development in Alzheimer’s disease as well as other disorders such as frontotemporal dementia.
Biogen said that target engagement was demonstrated in the study, with a lowering of N-terminal tau in the cerebrospinal fluid observed.
However, this did not lead to a statistically significant treatment effect on tau-PET at week 78 for any dose group.
In contrast, Biogen’s Alzheimer’s drug Aduhelm (aducanumab) – an anti-amyloid antibody – was approved by the US Food and Drug Administration (FDA) earlier this month, although the decision has been criticised by some experts.
Specifically, the FDA has come under fire from diverting away from the opinion of its Peripheral and Central Nervous System Drugs Advisory Committee, which voted against approval of the drug in AD in November 2020.
As a result of the FDA approval of Aduhelm, three members of the committee have resigned, including Aaron Kesselheim – a professor of medicine at Harvard Medical School – who said the authorisation “was probably the worst drug approval decision in recent US history”.
A patient in the US has become the first person to receive the therapy, which has debuted with a list price of $56,000 per year, outside a clinical trial.