First-in-Class Therapy Demonstrates Statistically Significant 2-Point Reduction (p=0.03) in Investigator’s Global Assessment (IGA)
AOBiome Therapeutics (“AOBiome”), a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced positive efficacy and safety findings from the Phase 2b clinical trial of the Company’s Ammonia Oxidizing Bacteria (AOB) product candidate for the treatment of mild-to-moderate acne vulgaris. AOBiome’s candidate is a first-in-class, topical formulation of a single strain of beneficial AOB, Nitrosomonas eutropha. The Phase 2b study achieved the primary endpoint at week 12 of a statistically significant 2-point reduction in an Investigator’s Global Assessment (IGA) of acne severity compared to vehicle control (p=0.03). The study also showed a trend in the reduction of the number of inflammatory lesions compared to control, a second primary endpoint; this difference reached statistical significance in the per protocol treatment group (p=0.028, log transformation analysis). AOBiome’s candidate was well-tolerated, demonstrating no treatment-emergent adverse events.
“We are proud of the continued success and progress of our acne program. This, coupled with the recently announced initiation of our Phase 1b/2a clinical trial for allergic rhinitis, highlights the versatility and broad utility of our anti-inflammatory platform.” said Todd Krueger, President of AOBiome. “Application of our AOB to more than 270 individuals across disease areas with virtually no side effects underscores the potential of our platform to address inflammation contributing to a broad range of diseases, supporting our continued leadership in the development of innovative therapeutics.”
AOBiome’s randomized, double-blind, placebo-controlled Phase 2b study evaluated AOB in 358 adults with mild-to-moderate acne vulgaris. Primary outcome measures of the Phase 2b study were designed to assess safety and efficacy as demonstrated by an Investigator Global Assessment and reduction in inflammatory and non-inflammatory lesion count during the 12-week treatment period. The Phase 2b study was jointly conducted with Science 37, a clinical research company, that has pioneered a “site-less” clinical trial model with its proprietary mobile technology, the Network Oriented Research Assistant (NORA®) used in the trial to capture real-time data from patients at their homes. The Principal Investigator of the study was Noah Craft MD, PhD, a dermatologist, microbiologist, and CEO of Science 37, Inc. A previous Phase 1b/2a dose-ranging safety study resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. Additional information about AOBiome’s Phase 2b study in acne may be found at ClinicalTrials.gov, using Identifier NCT: NCT02832063.
“We are very excited by these positive findings, which to our knowledge are the first to demonstrate that a single strain of beneficial AOB can have a clinically meaningful impact on acne, a known challenge with current available therapies,” stated Chief Medical Officer, Larry Weiss, MD. “In addition, safety and side effects are important challenges with marketed products and our ability to reduce disease severity with no treatment-related safety events offers a potentially differentiated profile to available interventions.”
Given the positive results of the Phase 2b study in acne, AOBiome plans to expand its dermatology platform to include atopic dermatitis, pruritus, and rosacea.
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 normally found on the body. Once deployed, AOB convert ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.
Acne affects approximately 40 to 50 million people in the U.S., where it is the most common skin condition and the top reported cause for dermatologist visitations, accounting for about one-fourth of U.S. dermatologists’ patient volume. U.S. sales of the Top 10 branded acne therapeutics have a $3 billion run rate. However, despite the significant spend on prescription and over the counter remedies, acne remains an area of significant unmet medical need as treatments are either marginally effective (topical antibiotics, topical retinoids, astringents) and/or associated with serious risks (oral retinoids).
About AOBiome Therapeutics
AOBiome Therapeutics is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local, nasal and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical stage therapeutic candidates. The company’s portfolio includes three clinical stage programs, a Phase 2b study to treat patients with acne vulgaris, a Phase 2 trial to reduce elevated blood pressure, and a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.
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