Biogen shelves gosuranemab after no benefit seen in Phase II Alzheimer's study
Biogen said Wednesday that it is ending development of the investigational anti-tau antibody gosuranemab after it missed the primary efficacy endpoint of the Phase II TANGO trial in patients with early Alzheimer's disease. The news marks the third clinical setback for the company this week, after its Sage Therapeutics-partnered drug zuranolone failed to impress in a much-anticipated depression study, while yet another retinal disease gene therapy stemming from its Nightstar Therapeutics purchase two years ago came up short in a Phase III study.
The TANGO trial enrolled 654 patients with mild cognitive impairment due to Alzheimer's disease or with mild Alzheimer's disease dementia. Participants were randomised to receive one of three doses of gosuranemab or placebo by intravenous infusion every four weeks, with the primary efficacy endpoint being change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) at week 78.
"Target engagement was demonstrated with lowering of N-terminal tau in cerebrospinal fluid (CSF), consistent with prior studies," Biogen said, but "no statistically significant treatment effect was observed on tau-PET…for any of the dose groups." It added that "no treatment benefit" was seen on exploratory efficacy endpoints either, including the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer's Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) and the Mini-Mental State Examination (MMSE). Analyses of additional data are ongoing, including CSF biomarkers, and Biogen plans to present the TANGO results at an upcoming medical congress.
Innovation path 'not a straight line'
"While we are disappointed by the results of the Phase II study…we know that the path to innovation is not a straight line, and that we always learn from each trial," remarked Alfred Sandrock, Biogen's head of R&D. He added that the company is "investing in a broad neuroscience pipeline, including other tau approaches for Alzheimer's disease."
The decision to terminate the gosuranemab programme comes in the wake of last week's FDA accelerated approval of the company's anti-amyloid antibody Aduhelm (aducanumab), partnered with Eisai. Controversy over that ruling continues, having spurred the resignations of three FDA advisory panel members, while consumer advocacy group Public Citizen on Wednesday called for the FDA's top brass to be ousted. Other Alzheimer's disease drugs in Biogen's pipeline include the anti-amyloid beta protofibril antibody lecanemab, also known as BAN2401, which is being co-developed with Eisai as well.
In 2019, Biogen ended developing gosuranemab, formerly also known as BIIB092, in progressive supranuclear palsy after it failed a Phase II trial in that patient population.
June 16th, 2021
https://www.firstwordpharma.com/
