AOBiome's 576 patient Phase 2b trial commences patient enrollment
CAMBRIDGE, Mass., June 30, 2020 /PRNewswire/ -- AOBiome Therapeutics, Inc. ("AOBiome"), a leading clinical-stage microbiome company focusing on inflammation, announced initiation of a Phase 2b clinical trial in pruritus (itch) associated with atopic dermatitis based on positive clinical trial results related to the investigation of its lead product candidate, B244, in patients with atopic dermatitis (eczema) in a Phase 2a clinical trial in adults, as well as a Phase 1b clinical trial in pediatric patients.
The adult trial was a double blind, placebo controlled, multicenter, Phase 2a study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria, delivered as a topical spray twice daily for 28 days. This trial was designed to assess safety and efficacy in 122 patients 18 years and older with mild-to-moderate pruritus associated with atopic dermatitis. Patients receiving the investigational drug achieved a statistically significant improvement in their pruritus over patients receiving placebo (p value = 0.01) after two weeks. In addition, 23% of patients receiving the drug achieved at least a 4 point improvement (out of 10) utilizing the visual analog scale (VAS) for pruritus, versus 6% of patients receiving placebo. B244 was very well tolerated and side effects of the active were equal to that of the placebo. This was consistent with all previous trials the company has completed with this drug. Typical itch drugs take significantly longer to show improvement, highlighting a significant market opportunity for the company.
The pediatric trial was an open-label, single dose level, multicenter, Phase 1b study of the B244 topical formulation, administered twice daily and was designed to assess its safety and tolerability in 28 pediatric patients aged 2 to 17 years with mild-to-moderate atopic dermatitis over a 28-day period. The drug was very well tolerated. 28% of patients achieved at least a two point (out of 5) improvement on the ITCHMAN pruritus scale at week four and 64% achieved at least a 1 point improvement.
Based on these early efficacy signals, a double blind, randomized, placebo controlled, multicenter, Phase 2b dose selection study 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 has begun, 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 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 will be 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.
"There is a significant medical need for new therapies to treat both adults and children with itch associated with atopic dermatitis. In younger populations, itch can be the primary complaint and can exacerbate the severity of disease through an itch-scratch-lesion worsening cycle. Our safety profile and rapid onset of efficacy has led us to focus on pruritus as the lead indication in our next clinical trial," said President & CEO, Todd Krueger. "We look forward to announcing results from this study in 2021."
In the United States, 12% of children (or 9.6 million) under the age of 18 years suffer from eczema and associated pruritus.1 Of these, approximately one third have moderate to severe cases. 7% of adults in the US suffer from eczema and associated pruritus.
"The potential beneficial effect of B244 on atopic dermatitis and its associated pruritus is multi-pronged. Pruritus relief may be mediated through an immunomodulatory mechanism of action. Pre-clinical results have shown that the bacteria exert an anti-inflammatory effect on certain markers associated with itch. Company studies have also shown the potential antimicrobial mechanism of action that contribute to the reduction of pathogenic bacteria infecting the established skin lesions," said Board of Director, Dr. Annalisa Jenkins, MBBS MRCP. "Furthermore, current therapies for pruritus can cause local side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244's innovative nature represents a novel therapeutic opportunity to safely address the medical needs of patients.
Additional information regarding this and AOBiome's other ongoing clinical programs may be found at www.clinicaltrials.gov.
About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.
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. The company's portfolio includes multiple clinical-stage programs: a completed Phase 2 study to treat patients with acne vulgaris or acne, a Phase 1b study to treat patients with pediatric eczema (atopic dermatitis), a Phase 2 study to treat patients with adult eczema (atopic dermatitis), a Phase 2 study for the prevention of episodic migraines, and a Phase 1b/2a clinical trial for the treatment of allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at www.aobiome.com.
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1 Hanifin J, Reed M. A Population-Based Survey of Eczema Prevalence in the United States. Dermatitis. 2007;18(2):82-91. doi:10.2310/6620.2007.06034.
2 Gustafsson, D., et al. "Development of Allergies and Asthma in Infants and Young Children with Atopic Dermatitis – a Prospective Follow–up to 7 Years of Age." The Canadian Journal of Chemical Engineering, Wiley-Blackwell, 9 Oct. 2008, onlinelibrary.wiley.com/doi/abs/10.1034/j.1398-9995.2000.00391.x.