CAMBRIDGE, Mass., June 16, 2021(Nasdaq: BIIB) today announced topline results from its Phase 2 TANGO study of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for Alzheimer's disease.
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, 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.
Gosuranemab is an antibody directed against the N-terminus of tau. Target engagement was demonstrated with lowering of N-terminal tau in cerebrospinal fluid (CSF), 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.
"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. We are investing in a broad neuroscience pipeline, including other tau approaches for Alzheimer's disease," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "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 clinical development of gosuranemab. Analyses of additional data, including CSF biomarkers, are ongoing, and Biogen plans to present these TANGO results at an upcoming medical congress.
About the Phase 2 TANGO Study
The Phase 2 TANGO (NCT03352557) 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 (MCI) due to Alzheimer's disease (AD) or with mild AD, followed by a dose-blind long term extension period. The study enrolled 654 participants across 97 sites. Participants aged 50-80 years with gradual and progressive change in memory function over more than 6 months, who met all of the clinical criteria for MCI due to AD or mild AD, had a CDR-SB of 0.5 for MCI due to AD or 0.5 or 1 for mild AD, a MMSE score of 22 to 30 (inclusive), a CDR Memory Box score of =0.5 and demonstrating amyloid-positivity by CSF or amyloid-PET were randomized to receive IV low, medium or high dose gosuranemab or placebo, once every 4 weeks. The primary endpoint of the study was safety.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.
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Biogen Safe Harbor Statement
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about results from the TANGO study; the potential clinical effects of gosuranemab; data readouts and presentations for gosuranemab; the identification and treatment of Alzheimer's disease; our research and development program for the treatment of Alzheimer's disease; the potential of our commercial business and pipeline programs; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
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