- ATx201 modulates biomarkers of cutaneous inflammation and skin barrier function in patients with moderate atopic dermatitis
- Analysis of safety data revealed ATx201 generally safe and well-tolerated in subjects with moderate AD lesion
Hellerup, Denmark: UNION therapeutics A/S today announced the publication of UNION's Phase 2 (ATx201-003) results in The Journal of Investigative Dermatology.
The study found topical application of ATx201 to be safe and to significantly impact biomarkers of relevance to the skin barrier function and inflammatory processes across multiple Th cell pathways associated with atopic dermatitis (AD).
The study was a randomized, double-blind, intraindividual, and vehicle-controlled Phase 2 trial. Thirty-one patients received ATx201 CREAM 2% and matching vehicle (1:1) once daily for three weeks, with a 12-day follow-up period.
The histological and transcriptional profiling analysis demonstrated that treatment with ATx201 significantly (p < 0.05) increased expression of biomarkers related to skin barrier function and decreased expression levels of markers related to inflammation and inflammatory cells compared to vehicle at Day 22. Lastly, several essential AD-biomarkers were significantly correlated with the AD clinical score TSS (p < 0.05).
"We are excited to see these findings published, thereby driving current research on atopic dermatitis closer to an understanding of the disease. The data shows ATx201 to be well tolerated and that it improves specific biomarkers essential in AD pathology," states Dr. Morten Sommer, Chief Scientific Officer, and continues, "Based on the biomarker data, we find ATx201 to be an interesting candidate offering a new treatment paradigm for atopic dermatitis patients."
The abstract is available online at The Journal of Investigative Dermatology: LINK
More study details can be found at clinicaltrials.gov: LINK