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Lancet Neurol: Tau protein monoclonal antibody Tilavonemab has no effect on the treatment of progressive supranuclear palsy!

 Last Update: 2021-03-21
 Source: Internet
 Author: User

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Progressive supranuclear palsy is a neurodegenerative disease associated with tau protein accumulation.

Tilavonemab (ABBV-8E12) is a monoclonal antibody that binds to the N-terminus of human tau protein.

This is a randomized, placebo-controlled, double-blind Phase 2 study conducted in 66 hospitals and clinics in Australia, Canada, France, Germany, Italy, Japan, Spain and the United States.

Research Process

From December 12, 2016 to December 31, 2018, a total of 378 patients were randomized.

Because the second interim analysis met the pre-specified invalidity criteria, the study was terminated on July 3, 2019.

Changes in PSPRS before and after treatment

A total of 377 subjects received at least one dose of the study drug and were included in the efficacy and safety analysis (2000 mg group, n=126; 4000 mg group, n=125; placebo group, n=126).

From baseline to week 52, the least squares mean change of each group of PSPRS was similar.

Changes in secondary endpoints before and after treatment

Most subjects reported at least one adverse event (111 cases in the 2000 mg group [88%]; 111 cases in the 4000 mg group [89%]; 108 cases in the placebo group [86%]).

In summary, similar safety characteristics were observed in all treatment groups in this study.

Similar safety characteristics were observed in all treatment groups in this study.

Original source:

Hoglinger Günter U, Litvan Irene, Mendonca Nuno et al.

org/10.
1016/S1474-4422(20)30489-0" target="_blank" rel="noopener">Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial in this message

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