First-in-Class Therapy to Locally Deliver Nitric Oxide.
Ongoing Phase 2b Study with Lead Candidate in Individuals with Mild-to-Moderate Acne Vulgaris
AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the Company’s Ammonia Oxidizing Bacteria (AOB) for the treatment of acne. The lead candidate is currently in development for multiple indications, including an ongoing Phase 2b study for acne vulgaris, and multiple earlier-stage clinical studies for allergic rhinitis and other inflammatory conditions. U.S. Patent No. 9,738,870 is directed to methods of use for AOB for the treatment of inflammatory or non-inflammatory lesions in individuals with acne vulgaris. “AOBiome is continuing to build a broad portfolio of patents and patent applications encompassing composition and methods of preparation and use across diverse therapeutic applications with compelling unmet needs,” said Todd Krueger, President of AOBiome. “We are pleased with the progress of our lead program with AOB in our ongoing Phase 2b clinical trial, which recently completed the last patient visits for individuals with mild-to-moderate acne vulgaris. We expect this study will provide important information regarding the potential of our promising therapeutic agent to treat acne while avoiding both local and systemic adverse effects that are often associated with current standard of care.” About Ammonia Oxidizing Bacteria (AOB)
AOBiome’s AOB platform is a patented, proprietary, topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. The platform is designed to repopulate the skin microbiome with AOB normally found on the body, but frequently stripped away by most soaps. Once deployed on the skin, 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. The Company’s multicenter, randomized, double-blind, placebo-controlled Phase 2b study is evaluating AOB in 358 adults with mild-to-moderate acne vulgaris. Primary outcome measures of the Phase 2b study are designed to assess safety and efficacy as demonstrated by Investigator Global Assessment and reduction in inflammatory and non-inflammatory lesion count during the 12-week treatment period. The Phase 2b study is being jointly conducted with Science 37, a clinical research organization. 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. About Acne
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
AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local 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 novel therapeutic candidates for systemic and local conditions. AOBiome’s lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is progressing clinical trials in allergic rhinitis and earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.
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