Johnson & Johnson’s Posdinemab Fails to Meet Primary Endpoint in Auτonomy Alzheimer’s Study

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Written By: Pharmacally Medical News Desk

Johnson & Johnson has discontinued its Phase 2b AuTonomy study in early Alzheimer’s disease after the investigational anti‑tau antibody posdinemab failed to demonstrate a statistically significant effect on slowing clinical decline at a scheduled interim review. The company announced the decision in a brief statement dated November 21, 2025, noting that the findings highlight the continued complexity of Alzheimer’s biology while reinforcing its commitment to Alzheimer’s research

About the AuTonomy study

The AuTonomy trial (NCT04619420) was a proof‑of‑concept, biomarker‑driven Phase 2b study designed as a first‑of‑its‑kind precision approach to test targeted intervention in participants with early Alzheimer’s disease. It evaluated intravenous posdinemab (also known as JNJ‑63733657), a monoclonal antibody directed against phosphorylated tau, with clinical decline measured using an integrated Alzheimer’s disease rating scale as the primary endpoint.

Key findings and decision

At a planned data review, posdinemab did not achieve statistical significance versus placebo in slowing clinical decline, meaning the primary efficacy goal of the study was not met. Based on these results, Johnson & Johnson decided to discontinue the AuTonomy study, and no further development within this specific trial will continue.

Company stance and next steps

In its statement, the company emphasized that despite this setback; it remains focused on transforming the future of Alzheimer’s care and continues to advance a broader pipeline of Alzheimer’s therapies, including additional tau‑targeting and other mechanistically distinct candidates. Johnson & Johnson also expressed gratitude to patients, caregivers, investigators, and site teams whose participation and data will inform ongoing and future research in this challenging disease area.

Reference

Johnson & Johnson Statement on the Autonomy Study, 21 November 2025, Johnson and Johnson, https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-the-au%CF%84onomy-study

A Study of JNJ-63733657 in Participants with Early Alzheimer’s Disease (Autonomy), ClinicalTrials.gov ID NCT04619420, https://clinicaltrials.gov/study/NCT04619420

 

 

 

 

 

 


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