Alphyn Biologics announced positive results from their Phase 2a trial of AB-101a will lead to a multinational Phase 2b trial soon.
Results from the Phase 2a clinical trial of AB-101a showed significant improvement in skin clearance of atopic dermatitis (AD), Alphyn Biologics recently announced in a press release. The company also stated that the first cohort from its clinical trial program showed itch reduction and control of AD flares.
AB-101a is a first-in-class topical treatment for AD in patients aged 2 through adult. The randomized, double-blind, vehicle-controlled trial followed 41 patients at 7 sites for 4 weeks to evaluate the efficacy of Alphyn’s AB-101 Multi-Target Therapeutic Platform.
The trial met all primary and secondary endpoints. The topical hydrogel reached statistical significance for improvement in Investigator Global Assessment (IGA) score. The IGA score reached clear or almost clear in 4 weeks for the 41 participants in the first cohort, and in the 81% mild AD population, in which improvement is difficult to demonstrate.
On the Eczema Area and Severity Index (EASI), AB-101a reached EASI75. Itch was reduced by day 4 of the trial. Control of the bacterial microbiome on the AD skin reached significant improvement on the Skin Infection Rating Scale (SIRS).
In the pediatric group, itch score improvement of 4 or greater increased continuously and was maintained after discontinuing use of AB-101a. Body Surface Area (BSA) was reduced by at least 50%.
The second cohort of the Phase 2a trial is an open-label study of 20 patients with mild, moderate, and severe AD with secondary infection. The trial will be assessing the control of the bacterial microbiome on AD skin.
AB-101a is the first therapeutic for AD to treat both the immune system element and the bacterial complications of the disease. The single-source botanical drug provides multiple bioactive compounds providing numerous mechanisms of action, including anti-inflammatory, anti-pruritic, and antibacterial.
"Overall, these findings are clear and compelling," said Neal Koller, chief executive officer of Alphyn Biologics in a news release. "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."
Alphyn plans to begin a multinational Phase 2b trial based on the positive findings.