Biogen’s Phase II study for gosuranemab, an anti-tau antibody for Alzheimer’s disease, did not meet its primary endpoint, and has therefore been terminated.
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, but the drug 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, 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.
Alfred Sandrock, Jr., Head of Research and Development at Biogen, said: “While we are disappointed by the results of the Phase II 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.
“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 any clinical development of gosuranemab.
The Phase II TANGO study of gosuranemab was a 78-week double-blind, placebo-controlled, parallel-group trial to evaluate both safety and efficacy on slowing rates of clinical progression in subjects with mild cognitive impairment due to Alzheimer’s disease (AD) or with mild AD, followed by a dose-blind long-term extension period.
Last week, Biogen’s controversial new drug, aducanumab, was accepted by the FDA, making it the first Alzheimer’s drug to be approved in nearly 20 years. Three FDA panel members have now quit in protest, as many experts are doubtful the drug actully works.
Lilly Subbotin
This is a syndicated feed from Pharmafile
