Improving Clinical Translation Through Human Skin-Based New Approach Methodologies
Adeline Chaubet1, Mathias Peries1, Mamoudou Diallo1, Laurianne Kandalaft1, Anthony David1, Emeline Pagès1, Nicolas Gaudenzio1,2
1Genoskin SAS, Toulouse, France & 2University of Toulouse, Inserm, CNRS, Toulouse Institute for Infectious and Inflammatory Diseases (Infinity), Toulouse, France.
Advancing drug development with New Approach Methodologies (NAMs)
Predicting human immune responses and local tissue reactions remains a major challenge in preclinical drug development. Differences between animal models and human biology can limit the clinical translation of safety findings, highlighting the need for human-relevant New Approach Methodologies (NAMs).
Genoskin’s HypoSkin® model preserves the native architecture and resident immune cells of human skin, enabling the investigation of local tissue responses following subcutaneous drug administration.
Presented at EUROTOX 2026 in Vienna, this study evaluated the ability of HypoSkin® to detect and characterize molecular and tissue responses associated with injection site reactions, demonstrating its potential to support human-relevant preclinical safety assessment.
HypoSkin® provides a human ex vivo platform to investigate local drug tolerability, characterize inflammatory responses, and generate meaningful data to inform drug development decisions.
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