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AOB Pharma Receives EMA Approval for B244

In a landmark decision, AOB Pharma has received a positive ruling from the European Medicines Agency (EMA) regarding its pediatric investigation plan (PIP) for B244, a first-in-class topical live biotherapeutic product aimed at addressing mild to moderate atopic dermatitis. This approval, granted on September 10, 2025, is particularly noteworthy as it facilitates the path for developing this innovative treatment across the European Union (EU) for children, adolescents, and adults.

B244 is poised for global Phase 3 clinical development, focusing on not just atopic dermatitis but also associated pruritus, a condition characterized by itchy skin. The EMA's Pediatric Committee (PDCO) published this favorable decision on November 6, 2025, detailing the implications of the ruling.

Significance of the EMA Decision

One of the most groundbreaking aspects of the EMA's approval is the granted waiver for the use of a topical corticosteroid (TCS) comparator in clinical studies for patients aged 12 and older. Historically, requirements for such comparators have created challenges for similar treatments, as evidenced by the marketing hurdles faced by products like Eucrisa and Opzelura. By acknowledging AOBiome’s position that B244 represents a more patient-friendly alternative with potential for better adoption and safety, the PDCO has set a precedent that could transform access to treatments for atopic dermatitis.

This PIP agreement aligns perfectly with prior endorsements from the U.S. FDA and Japan PMDA, which positions AOBiome favorably in the global market. The agreements allow AOBiome to initiate the initial Market Authorization Application (MAA) in Europe based on findings from planned Phase 3 trials without necessitating a comparator arm. This is a remarkable shift in the regulatory landscape, promising improved access for patients who have struggled to find effective treatments.

Supporting Partnerships

The successful navigation of the PIP process involved collaboration with Veristat, a leading global clinical research organization. Veristat provided comprehensive support, including guidance on strategy, document preparation, and communication with the EMA, enabling AOBiome to achieve this significant milestone.

Key elements of the agreement include the waiver for comparator studies and a pediatric deferral to begin studies in younger patients after completion of studies in older demographics. The FDA's previous approvals have further streamlined this path, making it easier to facilitate registration in essential markets like the EU and Japan.

Future Steps for AOB Pharma

AOBiome is now excited to move forward with a global Phase 3 study for B244, building on the promising results obtained from a previous 547-patient Phase 2b study. The continued focus on enhancing safety and efficacy in treatment options serves as a building block for improved patient care.

B244 is unique in its formulation, designed to produce nitric oxide, a compound known for its role in regulating inflammation. Preliminary clinical trials indicate that it is not only safe but also effective in lowering key inflammatory markers associated with atopic dermatitis. These characteristics could potentially transform the management of this chronic condition for many individuals.

As AOB Pharma prepares to initiate this pivotal study, industry experts and the community of patients await what could be a game-changing treatment option. With significant advancements in regulatory agreements and scientific research backing B244, the future looks promising for both AOB Pharma and patients suffering from atopic dermatitis globally.

For further updates, visit AOB Pharma's official website and the EMA's page for public announcements.