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Background <p>A placebo-controlled, double-blind Phase 1a trial examined the safety, tolerability, and pharmacokinetics of NNI-362 as well as the pharmacodynamic outcome of plasma phosphorylated tau<sup>181</sup> (p-tau<sup>181</sup>).</p> Methods <p>Oral NNI-362 and placebo were randomized in healthy, cognitively-unimpaired individuals (ages 50–72) at a 3:1 ratio, with sponsor, principal investigator, and subjects all blinded. Plasma levels of p-tau<sup>181</sup> were determined in the placebo and the two highest arms of 120 and 240&#xa0;mg NNI-362. Plasma biomarker was examined for statistical change from baseline.</p> Results <p>NNI-362 treatment was safe and well tolerated in older individuals. NNI-362, at the two highest multiple doses, significantly reduced plasma p-tau<sup>181</sup> levels compared to pretreatment levels (<i>P</i> &lt; 0.0012 to <i>P</i> &lt; 0.0009), while no change occurred in placebo groups.</p> Conclusions <p>These findings suggest in older subjects, oral NNI-362 appeared safe, well tolerated and reduced plasma p-tau<sup>181</sup>. Phase 2 studies of NNI-362 are warranted for Alzheimer’s disease and age-related degenerative disorders.</p> Trial registry number <p>NCT04074837. First registered: 2019-08-27.</p>

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First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年8月7日

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  • Judith Kelleher-Andersson,
  • Esther Yoon,
  • Carol Green,
  • Claire McFarlane,
  • Donya Bagheri,
  • Lynn Parker Thomas,
  • R. Scott Turner

摘要

Background

A placebo-controlled, double-blind Phase 1a trial examined the safety, tolerability, and pharmacokinetics of NNI-362 as well as the pharmacodynamic outcome of plasma phosphorylated tau181 (p-tau181).

Methods

Oral NNI-362 and placebo were randomized in healthy, cognitively-unimpaired individuals (ages 50–72) at a 3:1 ratio, with sponsor, principal investigator, and subjects all blinded. Plasma levels of p-tau181 were determined in the placebo and the two highest arms of 120 and 240 mg NNI-362. Plasma biomarker was examined for statistical change from baseline.

Results

NNI-362 treatment was safe and well tolerated in older individuals. NNI-362, at the two highest multiple doses, significantly reduced plasma p-tau181 levels compared to pretreatment levels (P < 0.0012 to P < 0.0009), while no change occurred in placebo groups.

Conclusions

These findings suggest in older subjects, oral NNI-362 appeared safe, well tolerated and reduced plasma p-tau181. Phase 2 studies of NNI-362 are warranted for Alzheimer’s disease and age-related degenerative disorders.

Trial registry number

NCT04074837. First registered: 2019-08-27.