Indero validates three-day gene expression method
Montreal-based contract research organisation Indero has completed an internally funded study demonstrating that quantitative gene expression analysis can assess topical new chemical entities in early-phase clinical research within three days, substantially reducing the time and cost associated with traditional evaluation methods.
The study, led by Dr Robert Bissonnette, Executive Chairman and Founder of Indero, utilised microdosing of a mid-potency corticosteroid on the skin of patients to evaluate gene expression changes. Results showed alterations in gene expression within 24 hours of application, with Th2, Th22, and Th17-specific biomarkers demonstrating significant reductions by 72 hours.
Microdosing approach reduces preclinical requirements
The methodology offers several advantages over conventional phase 1 studies, which typically require eight to 12 weeks of patient exposure. The three-day study protocol requires limited preclinical toxicology data and substantially reduces phase 1 costs. The approach enables researchers to compare multiple new chemical entities, concentrations, and vehicles within the same patient during short-duration studies, whilst also facilitating benchmarking against approved topical drugs.
“Our goal was to rethink how to study topical drugs in early phase studies,” said Dr Bissonnette. “The results of this study demonstrate that microdosing for only three days can provide meaningful efficacy signals.”
Gene expression analysis provides rapid biomarker assessment
Professor Emma Guttman, who performed the gene expression analysis, is Waldman Professor and System Chair of the Department of Dermatology, Director of the Asness Family Centre of Excellence in Eczema and Allergic Conditions, and Director of the Laboratory of Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai. She emphasised the paradigm shift represented by this strategy in topical drug development.
“This strategy represents a paradigm shift in topical drug development,” said Professor Guttman-Yassky. “It allows physicians and researchers to accelerate innovation whilst minimising patient exposure and resource use. The implications for both industry and patients are tremendous.”
The quantitative gene expression approach addresses a critical challenge in early-phase dermatological drug development by providing measurable efficacy signals with minimal patient exposure. Traditional evaluation methods require prolonged study periods to assess clinical endpoints, increasing costs and delaying the identification of promising candidates. By utilising molecular biomarkers associated with inflammatory pathways, the technique enables rapid screening of topical formulations before committing to extended clinical programmes.
Implications for dermatology research
The validated methodology could accelerate the development pipeline for topical therapies targeting inflammatory skin conditions. The ability to assess multiple formulations simultaneously within individual patients may improve study efficiency and reduce inter-patient variability in early-phase research. Clinical laboratories conducting dermatological research may find particular utility in adopting this gene expression-based approach for preliminary compound screening and formulation optimisation studies.
Indero operates as a dual-focus contract research organisation for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. The company provides services including protocol design, patient recruitment, trial monitoring, and biometrics across North America, Europe, Latin America, and Asia-Pacific regions.
- For more information, visit: inderocro.com
