EMA’s Positive PIP Decision Clears New Path for AOBiome’s B244 in Atopic Dermatitis

EMA’s Positive PIP Decision Clears New Path for AOBiome’s B244 in Atopic Dermatitis

By, Admin 3 December 2025

AOB Pharma, Inc. (AOBiome) has secured a major regulatory milestone for its lead topical therapeutic, B244, with the European Medicines Agency’s Pediatric Committee (PDCO) granting a positive Pediatric Investigation Plan (PIP) decision. The outcome, published on November 6, 2025, marks a meaningful step forward for the global development of this first-in-class live biotherapeutic for mild-to-moderate atopic dermatitis and pruritus.

Why This PIP Decision Matters?

The PIP process is often complex, lengthy and a major determinant of market access in Europe. AOBiome’s success—supported by Veristat’s regulatory consulting team—brings several advantages:

1. A Topical Corticosteroid Comparator Waiver

PDCO granted a TCS comparator waiver for AOBiome’s planned Phase 3 studies in adolescents and adults (12+ years).
This is significant because:

  • Previous topical AD drugs like Eucrisa and Opzelura could not gain European market access.
  • Their progress was blocked due to the requirement to include TCS comparators and demonstrate superiority or equivalence.
  • AOBiome now bypasses this barrier entirely.

PDCO acknowledged B244’s patient-friendly profile and its potential for improved adoption and safety, justifying the waiver.

2. Alignment with US FDA and Japan PMDA

The agreements align with prior regulatory guidance from the US FDA and Japan PMDA, ensuring:

  • A unified global Phase 3 strategy.
  • A direct path to a Marketing Authorization Application (MAA) in Europe based on two pivotal Phase 3 studies and one open-label extension study.
  • No need for an additional comparator arm or study.

3. Additional Regulatory Wins

  • Waiver for pediatric populations from birth to <1 month.
  • Deferral for younger pediatric studies until after adult/adolescent trials are completed.

What B244 Brings to the Table

B244 is a patented topical live biotherapeutic designed to produce nitric oxide, a key signaling molecule that helps regulate inflammation and vasodilation.
Key benefits observed so far:

  • Well-tolerated safety profile.
  • Reduction of inflammatory and pruritic cytokines, including IL-4, IL-5, IL-13, and IL-31.
  • Strong Phase 2b performance in 547 patients.

A global Phase 3 program for mild-to-moderate atopic dermatitis and associated pruritus is next in line.

Voices From the Industry

Kim Boericke, COO, Veristat, said:

“The PIP decision is the result of tremendous effort. We’re proud to partner with AOBiome and help advance milestones that ultimately improve patient lives.”

Hyun Kim, SVP Clinical Development, AOBiome, added:

“A TCS waiver is an exceptional regulatory outcome. It clears the way for European access, where patients have long faced barriers to new topical treatments.”

Why This Matters for Atopic Dermatitis Patients?

Atopic dermatitis patients in Europe have historically had limited access to novel topical therapies due to comparator design hurdles. The PDCO decision:

  • Opens a feasible approval path for B244.
  • Reduces development burdens.
  • Brings a potentially safer, more patient-friendly option closer to market.

About AOBiome

AOB Pharma, Inc. is based in Cambridge, MA and focuses on topical therapeutics for inflammatory skin conditions. The company is advancing multiple clinical-stage candidates built around its nitric oxide–modulating platform. Learn more at: aobiome.com

About Veristat

Veristat is a global CRO with 30 years of experience and over 100 regulatory approvals. The team specializes in complex, high-stakes studies across rare diseases, neurology, oncology, and advanced therapies.

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