CAMBRIDGE, Mass., April 13, 2017 /PRNewswire/ -- AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, announced today completion of patient enrollment in the Company's Phase 2 clinical trial of its lead product candidate, designated B244, to treat individuals with elevated blood pressure. The multicenter, randomized, double-blind, vehicle-controlled Phase 2 study is evaluating B244, a first-in-class, topical formulation of beneficial ammonia-oxidizing bacteria (AOB), in up to 116 individuals with either systolic prehypertension or systolic Stage 1 hypertension. Primary outcome measures of the Phase 2 study will address safety and provide an initial efficacy readout comparing mean reductions in systolic blood pressure in active and vehicle control groups in the 4-week treatment period.
"We are pleased with the rapid advancement of our Phase 2 program, which featured an effective patient recruitment campaign conveying the advantages of topical therapeutic application," said Todd Krueger, President of AOBiome. "The principal goal of the Phase 2 trial will be to confirm previous clinical findings, including positive safety results and data demonstrating the potential to lower blood pressure in human subjects. Based on our progress, we anticipate completing the trial in the second half of this year."
A previously conducted Phase 1b/2a acne study of B244 reported no serious adverse events and no difference in adverse events between treatment and vehicle groups among patients with acne vulgaris, an indication currently being tested in an ongoing Phase 2b study. Results from the Phase 1b/2a acne trial also showed dose-dependent reductions in blood pressure in normotensive subjects, achieving statistically significant decreases compared to placebo in patients receiving the highest treatment dose.
AOBiome's B244 is a patented, proprietary, topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. B244 is designed to repopulate the skin microbiome with AOBs normally found on the body, but frequently stripped away by most soaps. Once deployed on the skin, B244 converts ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.
"The ability to reliably and effectively deliver nitric oxide may benefit individuals with elevated blood pressure, including prehypertensive patients and those with Stage 1 hypertension, many of whom wish to avoid the adverse effects associated with currently approved blood pressure medications," stated Chief Medical Officer, Larry Weiss, MD. "Pending further confirmation in clinical studies, the promising safety data and blood pressure lowering activity of B244 have the potential to profoundly affect the quality of life of patients, and I look forward to the continued progress of the program."
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 eczema and earlier-stage preclinical programs targeting diverse indications. Learn more at AOBiome.com.
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