CHICAGO and BROOMFIELD, Colo., June 23, 2014 /PRNewswire/ -- MicroBiome TherapeuticsTM LLC, (MBT) today presented positive results from a clinical trial of microbiome modulator NM504 in prediabetes and type 2 diabetes at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society. This is the first double-blind, randomized, placebo-controlled trial to demonstrate that a microbiome modulator can improve blood glucose control and other metabolic parameters in patients with diabetes. NM504 is designed to shift the gastrointestinal (GI) microbiome to correct the GI dysbiosis, or microbial imbalances, that are associated with type 2 diabetes and prediabetes.
The trial was designed to assess whether NM504's modulation of the GI microbiome would result in better glycemic control in these patients. The results confirmed that NM504 significantly improved blood glucose control, lowering blood glucose and increasing levels of insulin in both patient populations. In addition, NM504 decreased cholesterol levels and markers of chronic inflammation in the treated patients. NM504 was well tolerated in the trial with no drug-related adverse events, and patient compliance was excellent.
Earlier this month the US Centers for Disease Control and Prevention issued its 2014 National Diabetes Statistics Report indicating the diabetes epidemic continues to grow at an alarming rate. Currently, some 29 million people in the US have diabetes and an additional 86 million American adults nearly one in three has prediabetes. An estimated 15 to 30% of people with prediabetes will go on to develop the full-fledged disorder within five years.
Vivian Fonseca, MD, FRCP, a member of the MBT Clinical Advisory Board, commented, "It is encouraging that NM504 significantly improved blood glucose control in this pilot study, and it did so in the absence of dietary changes or other diabetes medications. While preliminary, these results suggest that agents designed to modulate the GI microbiome may be a valuable new approach to managing type 2 diabetes. It is noteworthy too that NM504 was effective in lowering blood glucose in people with prediabetes, a rapidly growing population that could represent a future healthcare crisis in the absence of safe and effective tools to help prevent its progression to full-blown diabetes."
Dr. Fonseca was recognized at the American Diabetes Association Scientific Sessions last week as one of the highest ranking diabetes experts in the world. He is a Professor of Medicine, the Tullis-Tulane Alumni Chair in Diabetes, and Chief of the Section of Endocrinology at Tulane University Medical Center.
Steve Orndorff, PhD, CEO of Microbiome Therapeutics, noted, "We view the positive results of this study as proof of the concept that modulating the GI microbiome in specific ways can ameliorate the metabolic dysfunction of diabetes and prediabetes. NM504 met the primary endpoint of reducing blood glucose and it had positive effects on other important parameters. Microbiome modulators such as NM504 may represent a safe and effective new approach to managing these conditions, and MBT is proud to be a pioneer in advancing this promising new frontier of medicine."
MBT is developing microbiome modulators that alter microbial populations and their environment in the GI tract to address serious health conditions. The company's microbiome modulators are designed to act on multiple factors, augmenting the growth of targeted desirable bacterial strains and discouraging the growth of others. NM504 is formulated to promote microbiome shifts that positively affect metabolism and weight.
Dr. Mark Heiman, CSO of MicroBiome Therapeutics, presented Improved Oral Glucose Tolerance in Prediabetics and Type 2 Diabetics in a Pilot Clinical Trial Testing a Novel Gastrointestinal Microbiome Modulator, OR40-5, abstract 14546, at ICE/ENDO 2014 on June 23, 2014. For more information, visit www.endocrine.org/endo-2014.
About MicroBiome Therapeutics
MicroBiome Therapeutics LLC (MBT) is a clinical stage biotechnology company developing drug therapies that aim to improve health status by interacting with and altering the human microbiome. MBT is developing microbiome modulators for metabolic diseases. NM504 is being tested in clinical trials for the management of insulin sensitivity and blood glucose levels in prediabetic and obese individuals, and NM505 is a reformulation of metformin incorporating microbiome modulators for type 2 diabetic patients who are metformin intolerant. For more information, visit mbiome.com.
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SOURCE MicroBiome Therapeutics LLC