US 2026/0226544 A1Published application

Method for characterizing the onset, duration, and resolution of the biological effects of a therapeutic product

AssigneeBios-Therapy, Physiological Systems for Health S.p.A.

InventorsValentino MERCATI, Jacopo LUCCI

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Abstract

The present invention provides an innovative analytical strategy specifically designed to overcome the inherent limitations of the traditional ADME (Absorption, Distribution, Metabolism, Excretion) approach in the pharmacokinetic and pharmacodynamic characterization of natural matrices-based therapeutic or beneficial product, such as a product comprising or consisting of multicomponent botanical extracts. The invention provides a fundamentally different approach that is not based on the molecular profile (i.e., an approach independent to the standardisation of each and every “marker”) of the administered therapeutic or beneficial product. The novel approach proposed herein, captures the integrated, functional response of the organism to the administration of a therapeutic or beneficial product, i.e., relies on a methodology that characterizes the pharmacokinetic and pharmacodynamic behaviour of a therapeutic or beneficial product through functional biological response, independent of its chemical composition. This approach, although generally applicable also to conventional drugs and beneficial products, is particularly suitable for multicomponent products such as products comprising natural matrices, e.g., plant natural matrices such as plant extracts, parts, fractions or the like.

Claims10

Dependent claims

A method for functionally characterising the onset, duration, and resolution of the biological effects of therapeutic or beneficial product, said product preferably comprising one or more natural matrix, following its administration to a subject, the method comprising:

(a) extracting RNA from biological samples of different tissues obtained from living organisms at multiple time points following administration of said natural matrices-based product, hereinafter treated sample(s), and from corresponding biological samples obtained at the same time points from a sham control living organism, hereinafter sham control sample(s);
(b) performing a transcriptomic analysis comprising gene expression profiling on the extracted RNA from each of said treated and sham control samples;
and identifying, for each treated sample at each time point, transcriptomic perturbations in terms of significantly Differentially Expressed Genes (DEGs) relative to the corresponding sham-control sample;
(c) defining the onset, duration, and resolution profile of the biological activity induced by the administration of said product
wherein
the onset time point corresponds to the first time point at which a significant transcriptomic perturbation is observed in at least one of said treated samples with respect to the corresponding sham control sample;
the resolution time point corresponds to the last time point at which a significant transcriptomic perturbation is observed in said treated samples with respect to the corresponding sham control samples;
the duration corresponds to the time span between said onset and resolution time point;
the method providing said onset, duration, and resolution profiles of the biological effects of said product independent of direct quantification of individual chemical constituents thereof.

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