Using skin biopsies to measure target occupancy of anti-fibrotic molecules: assay development and application for zampilimab in a primate model of chronic kidney disease and in healthy human volunteers

Q: What type of study is this?

This is a Pre-Registered Trial study.

Linghong Huang; Rowann Bowcutt; Alison Bigley; Graham Ogg; Tim Schmidt; Geoffrey I. Johnston; Timothy S. Johnson

doi:10.1186/s12882-025-04467-8

November 21, 2025BMC NephrologyOpen Access

Using skin biopsies to measure target occupancy of anti-fibrotic molecules: assay development and application for zampilimab in a primate model of chronic kidney disease and in healthy human volunteers

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Key Points

The research aims to evaluate the use of skin biopsies to measure anti-fibrotic target occupancy of zampilimab in chronic kidney disease.
Developed an assay using skin biopsies.
Utilized a primate model of chronic kidney disease for initial testing.
Conducted a phase I study in healthy human volunteers to assess safety and efficacy.
Demonstrated zampilimab's inhibitory effect on TG2 in monkey kidneys and skins.
Skin biopsies proved to be accessible surrogates for evaluating kidney therapeutic outcomes.
The ex vivo model supports further application in antifibrotic drug development.

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Implication

Assay development shows proof of concept for zampilimab's effect on chronic kidney disease using skin biopsies.

Abstract

Zampilimab inhibited TG2 in cynomolgus monkey kidney and skin. Skin is an accessible surrogate tissue to assess kidney TO and predict TE, and our ex vivo model of skin biopsy has potential for application in the development of other antifibrotic therapeutics. A phase I first-in-human study of zampilimab in healthy volunteers (NCT02879877; 26/08/2016) will provide further proof of concept.

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Cite This Study

Huang et al. (2025) studied this question.

synapsesocial.com/papers/6924e405c0ce034ddc34f84d https://doi.org/10.1186/s12882-025-04467-8

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Using skin biopsies to measure target occupancy of anti-fibrotic molecules: assay development and application for zampilimab in a primate model of chronic kidney disease and in healthy human volunteers

Key Points

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Implication

Abstract

Discussion

Cite This Study

Using skin biopsies to measure target occupancy of anti-fibrotic molecules: assay development and application for zampilimab in a primate model of chronic kidney disease and in healthy human volunteers

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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