MicroBiome Therapeutics’ NM504 For Improving Blood Glucose Regulation Is First Microbiome Modulator to Receive U.S. Patent Allowance

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Two Pilot Clinical Trials Showed NM504 Improved Blood Glucose in Diabetics and Prediabetics; Initial Launch as Dietary Supplement for Healthy Blood Glucose Levels Slated for 2017

NM504 is the first GI microbiome modulator to be recognized by the USPTO. This broad patent covers the unique composition of ingredients in NM504 and its use as a microbiome modulator to better manage blood glucose levels.

MicroBiome Therapeutics (MBT) today reported that the U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance for the company’s patent application covering the composition and use of lead microbiome modulator NM504. The patent allowance covers NM504’s unique combination of ingredients as a human microbiome modulator for improving blood glucose regulation. The allowance includes use of NM504 in diabetic patients and prediabetics at risk of developing diabetes, and covers NM504 delivered in any format, including capsules, tablets, and food-like vehicles such as smoothies and nutrition bars.

Dale Pfost, PhD, Chief Executive Officer of MBT, commented, “As an early microbiome pioneer, it is fitting that our lead product NM504 is the first gastrointestinal (GI) microbiome modulator to be recognized by the USPTO. This broad patent covers the unique composition of ingredients in NM504 and its use as a microbiome modulator to better manage blood glucose regulation. In controlled pilot clinical trials, NM504 lowered post-meal blood glucose levels in people with Type 2 diabetes and prediabetes, and it helped control common side effects of the front-line drug metformin in diabetic patients. In these studies, NM504 also improved several other factors relevant to metabolism and weight, such as satiety. NM504 will initially be marketed as a dietary supplement to help maintain healthy blood glucose levels, with launch planned for 2017.”

In a double-blind, randomized, placebo-controlled clinical study(1), NM504 shifted the gut microflora of prediabetic and Type 2 diabetes patients in beneficial ways, significantly improving post-meal blood glucose and insulin levels.

NM504 is also covered by an issued 2015 U.S. patent for use in combination with metformin to mitigate the limiting GI side effects often encountered with metformin use. The ability of NM504 to improve tolerance of metformin in Type 2 diabetes was demonstrated in a pilot published clinical study(2).

MBT Chief Scientific Officer Mark Heiman, PhD, noted, “Countering the worldwide epidemic of obesity and other metabolic disorders requires new approaches to help individuals maintain healthy blood glucose levels and manage their weight. NM504 is the first in a new class of GI microbiome modulators that leverage our growing knowledge of the human microbiome to help restore the GI microbiota diversity and balance that are frequently lost as a result of our contemporary diets and lifestyles. We are very pleased that the U.S. Patent Office has recognized the novelty of this important invention.”

U.S. Patent Application No.:14/238,980, A Human Gastrointestinal Microbiome Modulating Food Supplement for Improving Blood Glucose Regulation, is expected to issue in the coming months.

(1)--http://www.mbiome.com/news/press-releases/554-2/
(2)--http://dst.sagepub.com/content/9/4/808

About MicroBiome Therapeutics
MicroBiome Therapeutics (MBT) is a biotechnology company developing novel approaches to metabolic disorders that aim to maintain good health by altering microbial populations and their environment in the GI tract. MBT’s microbiome modulators are designed to augment the growth of certain beneficial bacterial strains and discourage the growth of others. Lead product NM504 is a unique combination of naturally occurring ingredients that improved post-meal blood glucose levels in a pilot controlled clinical trial in prediabetes and Type 2 diabetes patients. In a second pilot clinical study, NM504 was shown to increase the tolerability and efficacy of the first-line diabetes therapy metformin. NM504 will initially be marketed as a dietary supplement to help individuals maintain healthy blood glucose levels. For more information, visit http://www.mbiome.com.

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Barbara Lindheim
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