J&J discontinues Alzheimer's study of tau-targeting antibody

Johnson & Johnson said Friday it has ended the Phase IIb AuTonomy trial evaluating posdinemab in patients with mild Alzheimer's disease.

The monoclonal antibody, which targets phosphorylated disease-associated tau, "did not achieve statistical significance in slowing clinical decline," the pharma said. It added that it "remain[s] committed to transforming the future of Alzheimer's care and confident in our pioneering pipeline of therapies."

J&J plans to share a full evaluation of the results, which it said "underscore the deep complexity of the disease," with the scientific community "in due course."

Tau-targeting strategy

J&J had been hoping that the targeted enrolment criteria for AuTonomy would increase its likelihood of success. Fiona Elwood, the company's VP and disease area stronghold leader for neurodegeneration, recently told FirstWord the study aimed to enrol "Goldilocks patients who have enough tau in their brains that they will have significant clinical progression that we can then measure and modify, but not so much that we can no longer block the spread of tau."

The drugmaker had even developed a proprietary p-tau217 blood-based biomarker as a pre-screening tool for AuTonomy, she said. For more from FirstWord's conversation with Elwood, see ViewPoints: J&J VP outlines 'Goldilocks' strategy for tau-targeted Alzheimer's trials.

In addition to posdinemab, J&J's tau-focused strategy to tackle Alzheimer's includes JNJ-2056, an active immunotherapy targeting phosphorylated tau it's developing in partnership with AC Immune. The candidate recently entered Phase II testing to delay or prevent cognitive decline in pre-symptomatic patients with Alzheimer's disease.

Both posdinemab and JNJ-2056 target epitopes adjacent to the microtubule binding domain of tau, the region of tau thought to drive aggregation, Elwood said.