The company plans to submit its new trial protocol to the FDA on July 10th, aiming to begin enrollment this fall across 13 clinical sites. The study will focus on 176 patients, testing the efficacy of B244, a patented formulation designed to produce nitric oxide to regulate inflammation and sebum production. By advancing this program now, AOB Pharma intends to generate clinical data faster, potentially creating a clearer path toward Phase 3 trials while simultaneously maintaining its global study timeline for atopic dermatitis.

Peter Lio, a founding partner at Medical Dermatology Associates of Chicago, noted that many patients struggle with the safety and tolerability of current acne therapies, suggesting that B244 could provide a necessary alternative. Todd Krueger, CEO of AOB Pharma, emphasized that the decision to run both the acne and atopic dermatitis programs concurrently demonstrates the company’s operational capacity. Biorasi, which previously collaborated with the biotech firm on earlier studies, has committed to overseeing the execution of this new trial with a focus on clinical discipline.