Following encouraging earlier-phase clinical data, the Company is advancing its acne trial ahead of schedule while maintaining atopic dermatitis global Phase 3 timeline.

AOB Pharma, Inc. ("AOBiome"), a leading clinical-stage biotechnology company focusing on inflammatory skin conditions, announced that it has partnered with Biorasi, a Clinical Research Organization to start the process of executing on its Phase 2b clinical trial in moderate to severe acne vulgaris. The Company previously partnered with Biorasi to run its global Phase 3 study in atopic dermatitis ("B244") in 2027. B244 had shown encouraging signals in earlier-phase studies in mild to moderate acne previously. Based on the clinical data generated to date and the significant unmet need in moderate to severe acne, the company has elected to focus its Phase 2b program on this patient population.

"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," says Peter Lio, MD, Founding Partner, Medical Dermatology Associates of Chicago.

"We look forward to our continued relationship with Biorasi. 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," says Todd Krueger, CEO and President of AOB Pharma. 

Biorasi President, Melissa Alesse, adds "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."

Accelerating the Phase 2 acne program is expected to offer several potential benefits, including:

• Earlier data readout: Beginning the trial this fall positions AOBiome to generate Phase 2 results sooner, potentially enabling a faster path to Phase 3 and, ultimately, subsequent regulatory milestones.
  
  
• Expanded pipeline momentum: Running acne and Atopic Dermatitis programs concurrently demonstrates the company's ability to advance multiple indications simultaneously, strengthening its clinical portfolio.
  
  
• 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 have issues with the side effect profile of existing drugs.
  
  
• Novel MoA designed to target anti-inflammatory activity, sebum production, and C. acnes, with earlier-phase clinical data supporting further evaluation.
  
  
• Competitive positioning: An earlier start improves AOBiome's position in the acne therapeutics landscape and could accelerate future business development opportunities.

The Phase 2 acne trial is expected to enroll 176 patients across 13 clinical sites. The Company intends to submit its new Phase 2b protocol to the FDA under its existing IND on July 10th. Full details of the trial design will be made available later this year.