Indero Announces Breakthrough Method for Early-Phase Evaluation of Topical Drugs Using Quantitative Gene Expression

Indero is proud to announce the successful completion of an internally funded study that introduces a novel approach to evaluating topical new chemical entities (NCE) in early-phase clinical research. This innovative method leverages quantitative gene expression analysis to assess drug efficacy rapidly and cost effectively.

Dr. Robert Bissonnette, Executive Chairman and Founder of Indero, who initiated and led the study, shared his excitement about the results:

“Our goal was to rethink how to study topical drugs in early phase studies. The results of this study demonstrate that microdosing for only 3 days can provide meaningful efficacy signals. Within just 24 hours, we observed alterations in gene expression after applying a microdose of mid-potency corticosteroid on the skin of patients. By 72 hours, Th2, Th22 and Th17-specific biomarkers were significantly reduced. This outcome is exactly what we hoped for and opens the door to faster, smarter drug development strategies, demonstrating the potential for this method to be used effectively in early phase 1 studies.” The study highlights several advantages of this approach:

• Rapid efficacy insights with limited preclinical toxicology requirements and reduced phase 1 costs (3-day study vs. 8–12 weeks).
• Ability to compare multiple NCEs, concentrations, and vehicles within the same patient in short-duration studies.
• Opportunity to benchmark NCEs against approved topical drugs efficiently.

Emma Guttman, Professor and Chair of Dermatology at Mount Sinai, who performed gene expression analysis, emphasized its impact:

“This strategy represents a paradigm shift in topical drug development. It allows physicians and researchers to accelerate innovation while minimizing patient exposure and resource use. The implications for both industry and patients are tremendous,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair, Department of Dermatology and Director, Asness Family Center of Excellence in Eczema and Allergic Conditions, and Director, Laboratory of Inflammatory Skin Diseases, the Icahn School of Medicine at Mount Sinai.

This breakthrough puts Indero ahead in dermatology research, creating a faster, safer, and more affordable way to develop topical treatments.

About Indero
Indero is a dual-focus CRO for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. Our full-service approach which includes everything from protocol design and patient recruitment to trial monitoring and biometrics provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Latin America, and Asia-Pacific; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal partner for clinical needs at global scale.

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