SAN FRANCISCO, June 10, 2019 /PRNewswire/ -- Whole Biome, an evidence-based microbiome company, today announced positive clinical results showing the efficacy of its proprietary microbiome Live SynbioticsTM formulation in improving glucose control in patients with type 2 diabetes (T2D). The clinical data was presented at the American Diabetes Association's (ADA) 79th Scientific Sessions, which took place June 7-11, 2019 in San Francisco.
"After conducting rigorous clinical trials examining our proprietary microbe formulations in subjects with type 2 diabetes, our data shows that our product is both effective and safe," said Orville Kolterman, MD, Chief Medical Officer of Whole Biome and senior author of the study. "Our unique discovery platform enables us to develop formulations that have targeted clinical efficacy with the safety profile of foods and natural supplements, resulting in products that are uniquely capable of restoring the body's natural, healthy state."
The poster presentation, titled, "Medical Food (MF) with Butyrate Producing (BP) + Mucin-Regulating (MR) Microbes Improves Glucose Control (GC) in T2D," describes the ability of Whole Biome's proprietary microbes to help restore glucose control to individuals with T2D who were being treated with metformin. In a double-blind, placebo-controlled, randomized study, the primary endpoint of the study was measured by changes in glucose spikes after a meal tolerance test in subjects receiving the medical foods compared to those receiving placebo. At 12 weeks, the data showed those who received the medical food yielded a 44 percent decrease in post-meal blood glucose spikes, as well as a 0.6 percent decrease in hemoglobin A1C. No safety or tolerability issues were observed in the study.
"Despite the many advances in diabetes management over the last 25 years, many patients struggle with complex treatment regimens and still have inadequate control of their disease and its comorbidities," said John Buse, MD, Ph.D., Chair, Division of Endocrinology at the University of North Carolina's School of Medicine. "The microbiome is a tantalizing and exciting modality to pursue to improve outcomes for the future, and Whole Biome is taking a methodical and rigorous, science-based approach to developing microbiome interventions."
Whole Biome's T2D product has been specifically formulated to restore microbes that metabolize dietary fibers that regulate blood sugar in the body.
"Through our proprietary discovery platform, we are able to identify novel strains and demonstrate meaningful evidence that supports the creation of an entirely new category of medical probiotics," said Colleen Cutcliffe, Co-Founder and Chief Executive Officer of Whole Biome. "In taking the extra steps of measuring the efficacy of our products in well-designed, placebo-controlled, randomized clinical trials, we are hoping to quickly bring effective and well-tolerated products to patients."
Whole Biome's T2D product has been certified as GRAS (Generally Recognized as Safe) by an independent third-party certifying organization, and the company intends to commercialize it in early 2020.
About Whole Biome
Whole Biome is an evidence-based microbiome company that is revolutionizing medicine by developing novel Live SynbioticsTM (combinations of bacterial strains and prebiotics), which target specific health conditions and provide the body the ability to naturally restore and improve one's health. The company has built a proprietary microbiome discovery platform and development approach that are enabling the identification of underlying microbiome mechanisms of action. This allows the company to develop a range of microbiome interventions for a variety of conditions, starting with metabolic diseases, to help improve patient health and wellbeing. Founded in 2012 and headquartered in San Francisco, California, Whole Biome is comprised of seasoned executives and a team with deep microbiology, biochemistry, computational, clinical and commercialization expertise. For more information, please visit www.wholebiome.com.
SOURCE Whole Biome