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.
Newly completed study aimed to understand the safety and potential benefits of the AOB's cellular structure without the production of nitric oxide and nitrite.
CAMBRIDGE, Mass., Aug. 17, 2021 /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a leading clinical-stage microbiome company focusing on inflammatory conditions, has announced the completion of a cosmetic study investigating the safety and effects of its novel AOB formulation on subjects with mild to moderate eczema. A total of 30 subjects used a cream containing metabolically inactive AOB twice a day for 2 weeks. Continuing the historically strong safety profile of applied AOB, the cream formulation was well-tolerated by the subjects. Subjects reported dramatic increase in multiple quality of life metrics throughout and a significant reduction in itch. The results of the study demonstrate immediate and sustained reductions in itch with the application of a probiotic skin cream in subjects between 2 and 65 years of age.
The impetus for the new eczema study was to better understand AOBiome's recently published data regarding the link between AOB in both a metabolically active and inactive state and the reduction of the itch-related cytokines IL-4 and IL-13. This study further bolsters the assessment of AOB as it relates to their current 576 patient Phase 2b pruritus study with live material. For more details see: https://www.nature.com/articles/s41598-021-93299-1
Key results from the Eczema study showed:
- The treatment was well tolerated with no SAE's reported
- Significant mean itch score improvements were observed in both adult and pediatric subjects throughout the study by VAS (0-10 scale) and Itch Man Scale (0-4 scale), respectively. Mean adult itch scores improved from 6.98±1.78 at Baseline to 3.01±2.22 at Day 14 (57% reduction), and mean pediatric itch scores improved from 2.64±0.67 at Baseline to 0.82±0.75 at Day 14 (69% reduction)
- 57.9% of adult subjects showed a 4-point improvement in itch (Visual Analog Scale) at Day 14 (11-point scale)
- 81.8% of pediatric subjects showed a 2-point improvement in itch (Itch Man Scale) at Day 14 (5-point scale)
- Significant reductions in itch were seen within the first hour of application
- The benefits for itch are sustained, with reductions from Baseline persisting an additional week after discontinuing use
- Subjects showed a statistically significant improvement in the appearance of eczema at Day 14 as compared to Baseline
The alleviation of itch symptoms was shown to have a significant improvement in the quality of life of the adult and pediatric subjects, as demonstrated by the dermatology life quality index (DLQI) and Children's Dermatology Life Quality Index (CDLQI) questionnaires. Both age groups showed an improvement in life quality at both Day 7 and Day 14, with their eczema improving to the point of only having a small effect on their daily life.
Chart 1: Reduced Itch Levels After 2 Weeks of Use
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Chart 2: Improved Quality of Life Scores After 2 Weeks of Use
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"These results show that AOB can still have a real world impact on the immune system when they are not consuming ammonia or no longer viable. This has huge implications for both the effectiveness of our clinical products and AOB persistence on the skin, as well as for the use of dead AOB as a beneficial ingredient in everyday consumer products," says President & CEO, Todd Krueger.
"Eczema is a huge unmet clinical need, especially in children. It is exciting to see the possibility of treating symptoms of eczema, especially itch, with a shelf stable formulation of AOB. This further reinforces the promising data that AOBiome has been generating." said Peter Lio, MD, FAAD, Clinical Assistant Professor of Dermatology & Pediatrics, Northwestern University Feinberg School of Medicine and founding director of the Chicago Integrative Eczema Center.
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. The Worst Itch NRS is a validated, self-reported instrument for measurement of itch intensity. Additionally, endpoints of Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) for Atopic Dermatitis will be captured. As this trial is being conducted during the COVID-19 era, patient and site staff safety will be of paramount concern. AOBiome has implemented a comprehensive risk mitigation plan to ensure such safety.
About AOBiome Therapeutics, Inc.
AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at www.aobiome.com.
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