B244 topical / AOBiome, Maruho - LARVOL DELTA

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) (PRNewswire) - "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...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 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....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."

European regulatory • New P3 trial • Atopic Dermatitis

Efficacy of Treatments in Reducing Facial Erythema in Rosacea: A Systematic Review. (PubMed, J Cutan Med Surg) - "The most effective topical treatments for reducing erythema include sodium sulphacetamide and sulphur, praziquantel, metronidazole, and B244 spray (Nitrosomonas eutropha). The most effective systemic treatment was paroxetine. Our findings highlight the varying efficacy of treatments in addressing the erythema in rosacea, recognizing the nuances of clinical presentations."

Journal • Review • Dermatology • Rosacea

Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials. (PubMed, Expert Opin Emerg Drugs) - "Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, Tapinarof, Lebrikizumab, Nemolizumab, Amlitelimab, and Rocatinlimab as they explore novel pathways and have some of the most promising results. These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects."

Journal • P2 data • P3 data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. (PubMed, EClinicalMedicine) - P2 | "B244 was well tolerated and demonstrated improved efficacy compared to vehicle in all primary, secondary, and exploratory endpoints and should be further developed as a novel, natural, fast-acting topical spray treatment option for AD and associated pruritus. AOBiome Therapeutics."

Journal • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain • Pruritus

AOBiome announces the publication of positive Phase 2b results in The Lancet's eClinicalMedicine for B244 in the treatment of mild-to-moderate atopic dermatitis and moderate-to-severe pruritus (PRNewswire) - P2b | N=547 | NCT04490109 | Sponsor: JAOBiome LLC | "AOBiome Therapeutics...has published a report describing the Company's Phase 2b clinical data for its B244 treatment for mild-to-moderate atopic dermatitis and moderate-to-severe pruritus....Itch was reduced by 34% (-2.8 B244 vs -2.1 Placebo) compared to placebo, as measured by the Worst Itch Numeric Rating Score (WI-NRS) and achieved a clinically meaningful itch response (30.8% B244 vs 21.8% Placebo in ≥4-point improvement in WI-NRS from baseline)....B244 was well-tolerated, with no serious adverse events. Treatment-emergent adverse events (TEAE) and treatment-related TEAEs were infrequent, mild, and transient."

P2b data • Atopic Dermatitis • Dermatology • Pruritus

B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis (clinicaltrials.gov) - P2 | N=547 | Completed | Sponsor: AOBiome LLC | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis (clinicaltrials.gov) - P2; N=576; Recruiting; Sponsor: AOBiome LLC; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

New 30 Patient Study Of AOBiome's New Shelf-Stable Formulation Of Its Ammonia Oxidizing Bacteria (AOB) Shows Reduction Of Itch Levels In Both Pediatric And Adult Subjects Who Suffer From Eczema (PRNewswire) - "AOBiome is currently running, a double blind, randomized, placebo controlled, multicenter, Phase 2b dose selection study which was initiated to evaluate the efficacy, safety, and tolerability of B244 topical spray twice daily for 28 days for the treatment of pruritus in 576 adults with a history of mild-to-moderate atopic dermatitis. Patient enrollment is ongoing, with approximately 50 US sites across 27 states participating in this trial. Primary efficacy endpoint and key secondary efficacy endpoint will include mean change in Worst Itch Numeric Rating Scale (WI-NRS) from baseline to week 4 and proportion of subjects with ≥4 point improvement in WI-NRS from baseline to week 4, respectively."

Enrollment status • Pruritus

A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: AOBiome LLC; Phase classification: P1/2 ➔ P1

Clinical • Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Pediatrics

AOBiome Reports Successful Clinical Trials (Phase 2a in Adults and Phase 1b in Pediatrics) in Pruritus (Itch) Associated with Atopic Dermatitis: Initiates Phase 2b Clinical Trial in Adults (PRNewswire) - "AOBiome Therapeutics...announced initiation of a Phase 2b clinical trial in pruritus (itch) associated with atopic dermatitis...Phase 1b clinical trial in pediatric patients....AOBiome's 576 patient Phase 2b trial commences patient enrollment...We look forward to announcing results from this study in 2021." "

Enrollment open • P1 data • P2b data • Trial status • Atopic Dermatitis • Dermatology • Pruritus

A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea (clinicaltrials.gov) - P2; N=140; Completed; Sponsor: AOBiome LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2; N=122; Completed; Sponsor: AOBiome LLC; Active, not recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Mar 2019

Clinical • Trial completion • Trial completion date

Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine (clinicaltrials.gov) - P2; N=314; Completed; Sponsor: AOBiome LLC; Active, not recruiting ➔ Completed; Trial completion date: Nov 2019 ➔ Jul 2019

Clinical • Trial completion • Trial completion date

A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=28; Completed; Sponsor: AOBiome LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=28; Active, not recruiting; Sponsor: AOBiome LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P1b/2a; N=71; Completed; Sponsor: AOBiome LLC; Active, not recruiting ➔ Completed; Trial completion date: May 2019 ➔ Dec 2018

Clinical • Trial completion • Trial completion date