MIAMI, FL / ACCESSWIRE / May 16, 2023 / Biorasi, a leading global full-service contract research organization (CRO), is proud to announce our inclusion in AOBiome Therapeutics' report on Phase 2b clinical data for its B244 treatment for mild-to-moderate atopic dermatitis and moderate to severe pruritus. The paper, entitled "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," is now available at eClinicalMedicine, part of The Lancet Discovery Science, an open access, peer-reviewed clinical journal. The article can be found at https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00179-7/fulltext.
Biorasi has worked with AOBiome on clinical trials since 2017 and partnered with them in December 2019 as the sole CRO for the B244 Phase 2b trial, recorded as the largest skin microbiome study to date. During the study, Biorasi provided comprehensive CRO services including Data Sciences, Project Management, Clinical Operations, and Medical and Scientific Affairs.
According to Todd Krueger, President and CEO of AOBiome Therapeutics, Inc., "This trial began only months after the start of the COVID-19 pandemic. The Biorasi team navigated this new environment deftly, allowing us to complete enrollment despite a Pandemic none of us could have prepared for. Having a nimble partner allowed us to complete the trial despite numerous challenges."
Biorasi was able to leverage its global team solutions across a 24-hour work cycle. This resulted in an accelerated turnaround time for the statistical analysis, surpassing current company benchmarks and delivering a completed analysis package to AOBiome in just 54 hours.
Dr. Peter Lio, of the Northwestern University Feinberg School of Medicine, states: "The improvements seen in itch reduction and eczema severity demonstrate the promise of B244 as a fast-acting treatment for AD. We are happy to share these results with the community at large."
The eClinicalMedicine paper provides a detailed analysis of how the study demonstrated significant efficacy of B244 at all clinical endpoints, including the improvement of itch, eczema severity, and quality of life metrics, as well as a strong safety profile at all dose levels.
In the trial, 547 patients were assigned to a high-dose, low-dose, or placebo group. After four weeks of use, the following results were obtained:
- 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)
- 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 26.2% and 21.7% of patients in the high and low dose groups of B244 achieved 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-relatedTEAEs were infrequent, mild, and transient.
About AOBiome Therapeutics, Inc.
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 rare disease, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data sciences. Contact Biorasi at info@biorasi.com / (786) 388-0700 or visit us online at www.biorasi.com.
SOURCE: Biorasi, LLC
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