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Posdinemab: Addressing the Unmet Need in Alzheimer Disease

Key Takeaways

  • Posdinemab, a phosphorylated tau-directed monoclonal antibody, is under investigation for early Alzheimer's disease and has received FDA Fast Track designation.
  • The phase 2b "AuTonomy" study is fully enrolled and utilizes a novel biomarker-based approach to investigate posdinemab.
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Here's why you should be paying attention to this new, upcoming Alzheimer disease treatment...

Fiona Elwood, PhD, shares more information about posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being investigated for the treatment of patients with early Alzheimer disease (AD), which just received Fast Track designation from the US Food and Drug Administration.

"The Alzheimer disease field is really changing very rapidly," Elwood told Psychiatric Times.

The phase 2b "AuTonomy" study, Elwood shared, which is investigating posdinemab in participants with early AD, is fully enrolled and ongoing (NCT04619420).

"One thing that's really exciting about this study is that we've used this really new biomarker based approach," said Elwood.

In addition to posdinemab, JNJ-2056, an investigational anti-tau active immunotherapy and the first active immunotherapy targeting tau in a preclinical AD population, also has Fast Track designation, granted back in July 2024.

You can read more about posdinemab here.

Dr Elwood is the Disease Area Stronghold Lead for Neurodegeneration at Johnson & Johnson.

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