Indero pioneers quantitative gene expression method for rapid topical drug evaluation
Indero, a contract research organisation (CRO) specialising in dermatology and rheumatology, has announced the completion of an internally funded study introducing a novel approach to early-phase evaluation of topical new chemical entities (NCEs). The method applies quantitative gene expression analysis to generate efficacy signals within days rather than the weeks or months typically required by conventional study designs.
A compressed timeline with meaningful signals
The study demonstrated that microdosing over just three days can yield clinically meaningful efficacy data. Using a microdose of a mid-potency corticosteroid applied to the skin of patients, the researchers observed measurable alterations in gene expression within 24 hours. By 72 hours, biomarkers specific to the Th2, Th22, and Th17 immune pathways were significantly reduced — findings consistent with expected anti-inflammatory activity in conditions such as atopic dermatitis.
Dr Robert Bissonnette, Executive Chairman and Founder of Indero, who initiated and led the study, commented: “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.”
Implications for early-phase clinical research
The approach offers several practical advantages for sponsors and investigators. A three-day study design substantially reduces the preclinical toxicology requirements and phase 1 costs compared with the eigh-to-twelve-week timelines associated with conventional topical drug evaluations. The methodology also permits direct comparison of multiple NCEs, concentrations, and vehicles within the same patient, and enables benchmarking against already-approved topical agents.
A shift in topical drug development strategy
Gene expression analysis was performed by Professor Emma Guttman-Yassky of the Icahn School of Medicine at Mount Sinai. She said: “This strategy represents a paradigm shift in topical drug development. It allows physicians and researchers to accelerate innovation while minimising patient exposure and resource use. The implications for both industry and patients are tremendous.”
Indero operates across North America, Europe, Latin America, and Asia-Pacific, providing full-service clinical research capabilities from protocol design through to biometrics.
For more information, visit: www.inderocro.com
