AOB Pharma receives European Medicines Agency (EMA) positive decision on the pediatric investigation plan (PIP), supporting future development of B244 for the treatment of mild to moderate atopic dermatitis in children, adolescents, and adults in the European Union (EU)

• B244, a first-in-class topical live biotherapeutic product, is currently planned for global Phase 3 development in mild to moderate atopic dermatitis and pruritus.
• EMA's Pediatric Committee (PDCO) agrees to AOBiome's PIP with a positive decision on September 10, 2025 and publishes in the EMA website on November 06, 2025, paving the path for development of B244 in the EU.
• PDCO decision includes granting a topical corticosteroid (TCS) comparator waiver in Europe for AOBiome's planned Phase 3 pivotal studies in adolescents and adults ages 12 years and older for the initial registration in Europe. This waiver is a departure from prior TCS comparator requirements for Eucrisa and Opzelura which have prevented their market access in Europe.
• PIP agreements align favorably with prior agreements reached with the US FDA and Japan PMDA on the Phase 3 program.

CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- AOB Pharma, Inc. ("AOBiome"), a leading clinical-stage biotechnology company focusing on inflammatory skin conditions with their lead asset B244 for the treatment of mild to moderate atopic dermatitis (AD) and pruritus, received a positive decision on the pediatric investigation plan (PIP) from the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) on September 10, 2025 and subsequently published in the EMA website on November 06, 2025 (https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/ema-pe-0000232853).

The extensive PIP process that resulted in a positive decision was supported by Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies.  Veristat's regulatory consulting arm provided end-to-end support, partnering with AOBiome on the development of the PIP strategy, document development, submission, and communication with EMA PDCO which eventually led to the positive decision.   

Key elements of the PIP agreements include receiving a topical corticosteroid (TCS) comparator waiver in Europe for AOBiome's planned Phase 3 pivotal studies in adolescents and adults ages 12 years and older that will allow a path for initial registration in Europe.  PDCO acknowledged that the product is intended as a more patient-friendly treatment with potential for better patient adoption and an improved safety profile and therefore accepted AOBiome's request for a TCS waiver.  This is a departure from previous decisions with other topical AD products including Eucrisa and Opzelura, which have not been able to gain market access in Europe to date, due to pricing and reimbursement issues stemming from the requirement for inclusion of TCS comparators and the need to demonstrate superiority or equivalence in their outcomes.  PDCO acknowledged that the product's effect may be supported by endpoints for the assessment of the use of TCS as rescue medication, which AOBiome already plans to implement in its study designs.

This agreement will allow AOBiome to file the initial Market Authorization Application (MAA) to the EMA based on the outcomes of the 2 pivotal and 1 open-label extension (OLE) studies in adolescents and adults as currently planned and endorsed by the US FDA and Japan PMDA without the need for a comparator arm or study.  Other agreements with PDCO include receiving a waiver on the pediatric population from birth to less than 1 month of age, and a pediatric deferral to initiate the pediatric study after AOBiome's pivotal studies are completed in adolescents and adults.  Overall, PIP agreements align favorably with the prior agreements reached with the US FDA and Japan PMDA on the global Phase 3 program that will allow registration in these key markets, with the Japan development currently supported by AOBiome's ongoing development and license partnership with Maruho Co., Ltd.

"The PIP positive decision is a culmination of tremendous effort by AOBiome and Veristat's regulatory consulting team.  We are proud of our ongoing partnership with AOBiome to deliver meaningful milestones that will ultimately improve patients' lives." says Kim Boericke, Chief Operations Officer at Veristat.

Hyun Kim, SVP Clinical Development at AOBiome, says, "Achieving a positive PIP decision with a TCS waiver is an exceptional regulatory outcome that opens European market access. We're especially excited about what this means for atopic dermatitis patients in Europe who have faced significant barriers to accessing new topical treatments."

AOBiome is currently preparing to initiate a global Phase 3 study to evaluate B244 for the treatment of mild-to-moderate Atopic Dermatitis and associated moderate-to-severe itch, following the successful completion of a 547 patient Phase 2b study.

About B244

AOBiome's B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be safe and well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About Veristat

Veristat is a full-service CRO and consultancy that helps life sciences companies bring novel therapies to market fast. With 30 years of experience and support in more than 100 regulatory approvals and deep expertise in rare disease, neurological disease, oncology, and advanced therapies, Veristat integrates strategic planning, regulatory insight, and trial execution to overcome complex challenges and accelerate success. From early planning through approval, Veristat delivers tailored solutions that drive meaningful outcomes for patients worldwide. For more information, visit www.veristat.com.

About AOB Pharma, Inc.

AOB Pharma, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.

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SOURCE AOBiome Therapeutics