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

16 May 2023
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Clinical ResultPhase 2Microbial therapyPhase 1
The peer-reviewed publication describes the significant effects of B244 in 4 weeks across key endpoints in adult patients with atopic dermatitis and associated pruritus (itch) in the largest study of B244 to date.
The study demonstrated significant efficacy of B244 across all clinical endpoints, including the improvement of itch, eczema severity, and quality of life metrics.
Study results reiterate B244's strong safety profile at all dose levels, confirming prior clinical trial safety results.
B224 is an investigational therapy currently under regulatory review in the U.S. These study results support the advancement of B244 to Phase 3.
CAMBRIDGE, Mass., May 16, 2023 /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a leading clinical-stage biotech company focusing on inflammatory conditions, today announces that The Lancet's eClinicalMedicine, a peer-reviewed medical journal, 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. The paper, titled "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," provides a detailed analysis of the Phase 2b trial, showing that B244 demonstrated significant improvements in eczema severity and itch reduction. The article can be freely accessed  via the following link: https://www-thelancet-com.libproxy1.nus.edu.sg/journals/eclinm/article/PIIS2589-5370(23)00179-7/fulltext
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In the trial, 547 patients were assigned to a high-dose, low-dose, or placebo group. The trial was run across more than 50 clinical sites in the US, in collaboration with Biorasi, LLC, a leading Clinical Research Organization. After 4 weeks of use, the following key results were obtained:
AOBiome's publication in The Lancet's eClinicalMedicine for B244 in the treatment of atopic dermatitis and pruritus
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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).
Eczema severity improvements were also seen, with 29.3% and 27.7% of patients in the high and low dose groups of B244 achieving EASI-75 success vs. 15.8% in the placebo group and with 26.2% and 21.7% of patients in the high and low dose groups of B244 achieving IGA success (≥2-point improvement in IGA to clear or almost clear) vs. 12.3% in the placebo group.
B244 was well-tolerated, with no serious adverse events. Treatment-emergent adverse events (TEAE) and treatment-related TEAEs were infrequent, mild, and transient.
Dr. Jonathan Silverberg, Director of Clinical Research at the George Washington University School of Medicine and Health Sciences, says "B244 is a promising new non-steroidal therapy for AD, with a very novel mechanism of action. The study was well designed and the results are very promising. B244 may address a number of unmet needs for atopic dermatitis patients."
According to Todd Krueger, President and CEO of AOBiome Therapeutics, Inc., "This publication represents the recognition of B244's efficacy and differentiation in addressing this population. The fact it has so few side effects reinforces the commercial opportunity to become first line therapy before patients escalate to more expensive, risky, or invasive therapies."
About B244
AOBiome's B244 platform is a patented, proprietary, topical formulation of ammonia oxidizing bacteria. 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, and IL-13. See full article at: https://www-nature-com.libproxy1.nus.edu.sg/articles/s41598-021-93299-1.
AOBiome Therapeutics, 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.
About Biorasi
Biorasi is a customer-focused, full-service, contract research organization (CRO) that delivers fast and flexible solutions across global clinical trials to maximize speed-to-market for its sponsors. As the leader in clinical trials for dermatology, neurology, oncology, and the rare disease market, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data sciences. Contact Biorasi at [email protected] / (786) 388-0700 or visit us online at www.biorasi.com.
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