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| Home > Workflow collections > In process > Pharmacokinetic properties of the clinical drug candidate PRI-002 with regard to genotype, sex, age, dose-dependence and food effects in mice |
| Journal Article | FZJ-2026-04425 |
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2026
Elsevier
New York, NY [u.a.]
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Please use a persistent id in citations: doi:10.1016/j.ejps.2026.107649
Abstract: The d-enantiomeric peptide RD2 (named Contraloid or PRI-002 in clinical trials) was developed for the direct disassembly of toxic amyloid-β (Aβ) oligomers, which are the most neurotoxic aggregate species and play a key role in the development and progression of Alzheimer´s disease (AD). PRI-002/RD2 already demonstrated its safety and tolerability in three phase I clinical trials in young healthy volunteers and patients with mild neurocognitive impairment (MCI) or mild dementia due to AD. Results from a phase II clinical trial with PRI-002/RD2 are expected this year, which was designed to demonstrate safety and efficacy of PRI-002/RD2 in patients at an early stage of AD. The objective of this study was to evaluate the effect of age, sex, genotype and food on the pharmacokinetics of intravenous or orally administered RD2 in male and female transgenic APPswe/PS1ΔE9 (APP PS1) (n = 62) or wild type (wt) mice (n = 169) under fed and fasted conditions. Age and concomitant food intake influenced the pharmacokinetics of RD2. Slightly higher plasma and brain levels were observed in young compared to old wt mice. However, the effect of food on plasma levels depended on the RD2 dose administered. While at lower doses (200 mg/kg) the effect was substantial, plasma levels were 15 times higher in fasted than in non-fasted animals, the effect was only minor at higher RD2 doses (600 mg/kg). The results of this study indicate the important influence of prior food intake on the bioavailability of the compound, which may also apply to patients and is therefore of interest in further clinical development.
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