CAMBRIDGE, Mass., July 1, 2026
AOB Pharma has entered into a strategic partnership with global clinical research organization Biorasi to launch a Phase 2b clinical trial evaluating its investigational topical therapy B244 in patients with moderate to severe acne vulgaris. The collaboration marks an important milestone for the clinical-stage biotechnology company as it accelerates development of its acne program ahead of schedule while maintaining progress on its planned global Phase 3 atopic dermatitis study. The decision follows encouraging earlier-phase clinical data demonstrating the potential of B244, a proprietary nitric oxide-producing topical therapeutic designed to address inflammation, sebum production, and Cutibacterium acnes (C. acnes), three key drivers of acne. By expanding development into patients with moderate to severe disease, AOB Pharma aims to address one of dermatology’s largest unmet medical needs while strengthening its inflammatory skin disease pipeline. The partnership with Biorasi, which previously managed the company’s successful Phase 2b study, reflects continued confidence in the clinical strategy and provides operational expertise to support efficient execution of the next stage of development.
Phase 2b Program Targets Moderate to Severe Acne
The upcoming Phase 2b clinical trial is expected to enroll 176 patients across 13 clinical sites and will evaluate the safety, tolerability, and efficacy of B244 in individuals with moderate to severe acne vulgaris. AOB Pharma plans to submit the updated Phase 2b protocol to the U.S. Food and Drug Administration (FDA) under its existing Investigational New Drug (IND) application, supporting trial initiation later this year.
The accelerated timeline is expected to generate clinical data sooner, potentially enabling faster progression into Phase 3 development and subsequent regulatory milestones. According to the company, initiating the acne program ahead of schedule also allows simultaneous advancement of both acne and atopic dermatitis programs, demonstrating the company’s ability to expand multiple late-stage dermatology indications while strengthening its overall clinical development portfolio.
Innovative Nitric Oxide Technology Addresses Unmet Need
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B244 is a patented, proprietary topical therapeutic developed to generate nitric oxide, a naturally occurring signaling molecule involved in regulating inflammation, immune responses, and vascular function. Earlier clinical and laboratory studies have demonstrated that the therapy is safe and well tolerated, while published immunology research has shown its ability to reduce inflammatory cytokines including IL-4, IL-5, IL-13, and IL-31, which play important roles in inflammatory skin diseases. Unlike many currently available acne therapies that primarily target bacteria or oil production individually, B244 is designed to simultaneously reduce skin inflammation, regulate sebum production, and target C. acnes, offering a novel mechanism of action with the potential for improved safety and tolerability. With approximately 50 million Americans affected by acne annually, there remains substantial demand for innovative treatments capable of delivering effective disease control while minimizing adverse effects associated with existing therapies.
Strategic Partnership Strengthens Dermatology Pipeline
The expanded collaboration reinforces the long-standing relationship between AOB Pharma and Biorasi, combining innovative therapeutic development with experienced global clinical trial execution. Biorasi will oversee operational management of the Phase 2b study, leveraging its expertise in supporting emerging and mid-sized biopharmaceutical companies through efficient clinical development programs. For AOB Pharma, advancing the acne program alongside the planned global Phase 3 atopic dermatitis trial significantly strengthens its inflammatory dermatology pipeline while enhancing future business development opportunities.
As competition continues to increase within the dermatology therapeutics market, successful advancement of B244 could establish the therapy as a differentiated treatment option for patients with moderate to severe acne who require alternatives to conventional therapies. With regulatory preparations underway and patient enrollment expected to begin this year, the collaboration positions both organizations to accelerate the development of a potentially important new therapy addressing significant unmet needs in inflammatory skin disease.
Source: AOB Pharma press release
