AOB Pharma Partners with Biorasi to Accelerate Phase 2b Trial of B244 in Moderate-to-Severe Acne
核心洞察
AOB Pharma (搜索) has partnered with CRO Biorasi (搜索) to execute a Phase 2b clinical trial of its topical nitric oxide-producing B244 platform in moderate-to-severe acne vulgaris (搜索).
The trial will enroll 176 patients across 13 clinical sites, with the new protocol being submitted to the FDA under an existing IND on July 10, and the trial beginning this fall.
B244 previously demonstrated encouraging signals in mild-to-moderate acne and has published immunology data showing reduction of inflammatory and pruritic cytokines IL-4 (搜索), IL-5 (搜索), IL-13 (搜索), and IL-31 (搜索).
AOB Pharma (搜索), Inc. (AOBiome), a Cambridge, MA-based clinical-stage biotechnology company focused on inflammatory skin conditions, announced on July 1, 2026 that it has partnered with Clinical Research Organization Biorasi (搜索) to begin executing a Phase 2b clinical trial evaluating its B244 platform in patients with moderate-to-severe acne vulgaris (搜索). The company is advancing the acne program ahead of schedule while maintaining its global Phase 3 timeline in atopic dermatitis (搜索) (AD).
The Phase 2b acne trial is expected to enroll 176 patients across 13 clinical sites. AOBiome intends to submit its new Phase 2b protocol to the U.S. Food and Drug Administration (FDA) under its existing investigational new drug (IND) application on July 10. Full details of the trial design will be disclosed later this year.
Novel Mechanism of Action
AOBiome's B244 platform is a patented, proprietary topical formulation that, once deployed, produces nitric oxide — a signaling molecule known to regulate inflammation and vasodilation. Published immunology data have demonstrated that B244 can reduce the inflammatory and pruritic cytokines interleukin (IL)-4, IL-5 (搜索), IL-13 (搜索), and IL-31 (搜索) (Bhatt et al., Scientific Reports, 2021). B244 has been observed to be safe and well-tolerated in clinical studies to date.
The novel mechanism of action is designed to target anti-inflammatory activity, sebum production, and Cutibacterium acnes, with earlier-phase clinical data supporting further evaluation in the moderate-to-severe acne population.
Significant Unmet Need
Acne affects an estimated 50 million Americans annually, and new therapeutic options — particularly those with novel mechanisms of action — are needed for patients who do not respond adequately to existing treatments or who experience issues with the side effect profiles of currently available drugs.
"B244 has generated encouraging data in earlier studies, and I'm excited to see it being evaluated in patients with moderate to severe acne. Despite the number of available acne treatments, many patients continue to struggle with disease control, treatment tolerability, and safety concerns, so B244 has the potential to provide an important new treatment option," said Peter A. Lio, MD, FAAD, a Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University Feinberg School of Medicine and Founding Director of the Chicago Integrative Eczema Center.
Strategic Acceleration and Pipeline Momentum
The company previously partnered with Biorasi (搜索) to run its global Phase 3 study in atopic dermatitis (搜索), expected in 2027. B244 had shown encouraging signals in earlier-phase studies in mild-to-moderate acne, and based on the clinical data generated to date and the significant unmet need in moderate-to-severe acne, the company elected to focus its Phase 2b program on this patient population.
Beginning the trial this fall positions AOBiome to generate Phase 2 results sooner, potentially enabling a faster path to Phase 3 and subsequent regulatory milestones. Running acne and atopic dermatitis (搜索) programs concurrently demonstrates the company's ability to advance multiple indications simultaneously, strengthening its clinical portfolio. An earlier start also improves AOBiome's competitive position in the acne therapeutics landscape and could accelerate future business development opportunities.
"We look forward to our continued relationship with Biorasi (搜索). They previously executed our Phase 2b study and we look forward to running another trial focused on an indication where patients would benefit from additional treatment options," said Todd Krueger, CEO and President of AOB Pharma (搜索).
Biorasi (搜索) President Melissa Alesse added: "AOBiome's decision to advance this program reflects confidence in both their clinical strategy and pipeline. We are pleased to continue our partnership and are ready to execute with discipline, reliability, and proven operational excellence."