Johnson & Johnson will discontinue the Phase II Auτonomy study of posdinemab after a scheduled review found the anti-tau antibody failed to slow clinical decline in patients with early Alzheimer’s disease.
It’s been a rough few days for the Alzheimer’s space. Three days before Novo Nordisk’s very high-profile GLP-1 failure, Johnson & Johnson reported a mid-stage disappointment of its own with posdinemab, an anti-tau antibody.
After a scheduled review found that posdinemab failed to achieve statistical significance in slowing clinical decline, the company is ending the Auτonomy study, J&J announced on Friday. Auτonomy was a “first-of-its-kind precision approach to evaluating targeted intervention in early Alzheimer’s disease,” according to J&J.
The Phase II study, which according to its Clinicaltrials.gov page, kicked off in January 2021, enrolled more than 500 patients with early Alzheimer’s disease who were randomized to receive either the study drug or placebo. The primary endpoint assessed posdinemab’s effect on clinical decline via the iADRS, a scale measuring cognition and function, at 104 weeks. The trial was expected to be complete in February 2026.
“The initial findings underscore the deep complexity of the disease, and together with the forthcoming analyses, will offer valuable insights that will shape ongoing and future research as the understanding of Alzheimer’s biology evolves,” the company said.
J&J plans to share full data at a later date.
Coming ahead of the Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place next week in San Diego, posdinemab’s failure is another setback not only for the broader Alzheimer’s space but also for the hypothesis that antibodies that bind to tau can make a dent in the intractable neurodegenerative disease. Last November, UCB’s anti-tau Alzheimer’s candidate bepranemab also failed to improve cognition and function in a Phase II trial—a month after partner Roche abandoned the collaboration.
Eisai will present data next week at CTAD on its anti-tau antibody etalanetug, “including its impact on a novel plasma tau biomarker,” in patients with dominantly inherited Alzheimer’s disease (DIAD). The oral presentation will be Dec. 1.
