Alphyn Biologics recently announced results from the first cohort of its Phase 2a clinical trial program of AB-101a in treating atopic dermatitis (AD) in children aged two years to adulthood. The trial’s data showed skin clearance of the disease, along with significant itch reduction, and control of AD flares by treating the bacterial microbiome on the AD skin.
AB-101a is a hydrogel topical that uses Alphyn’s proprietary AB-101 Multi-Target Therapeutic Platform. The randomized, double-blind, vehicle-controlled study evaluated the safety and efficacy of AB-101a in 41 patients at seven sites over a four-week period.
Results showed the trial met all of its primary and secondary endpoints.
The topical hydrogel reached statistical significance for improvement in Investigator Global Assessment (IGA) score, reaching clear or almost clear in just four weeks for the 41 participants in the first cohort.
Results also demonstrated an Eczema Area and Severity Index (EASI) of 75 as well as itch reduction by day four of the trial. Researchers also noted significant and steady improvement in the Skin Infection Rating Scale, demonstrating control of the bacterial microbiome on the AD skin to manage AD flares and prevent infection. A Body Surface Area reduction of at least 50% was also noted.
Furthermore, in the pediatric group, itch score improvement equal to or greater than four increased continuously and was maintained even after discontinuing AB-101a.
Alphyn Biologics’ AB-101a is being studied in two cohorts. The second is an open-label study evaluating patients with mild, moderate, and severe AD with secondary infection and control of the bacterial microbiome on the AD skin. Enrollment has been completed for the trial and is expected to conclude with 20 patients.
"Overall, these findings are clear and compelling. While we are particularly excited about the statistically significant improvements in IGA and EASI scores, which were notably achieved in an overwhelmingly mild population with only 41 patients and in only four weeks, we are also very encouraged by the fast itch reduction and unique aspects of skin microbiome control to manage AD flares which are primarily caused by bacteria."
