MicroBiome Therapeutics Reports Advances In Three Microbiome Modulator Programs As It Launches Series B Financing

-- New Publication Confirms NM505, a Combination of a Microbiome Modulator and Metformin, Significantly Improves GI Tolerability and Blood Glucose Control versus Metformin Alone --

-- Fast Track Patent Application for Microbiome Modulator NM504 as a Treatment for Obesity and Diabetes Receives Notice of Allowance from US PTO --

-- Preclinical Data Presented at ACS National Meeting Shows Microbiome Modulator MT303 Stimulates Microbiome Diversity and Improves GI Function --

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MicroBiome Therapeutics LLC

Apr 07, 2015, 07:30 ET

BROOMFIELD, Colo., April 7, 2015 /PRNewswire/ -- MicroBiome Therapeutics^TM LLC, (MBT) today reported advances in its microbiome modulator development programs as it prepares to initiate a Series B equity financing.

First, a newly-published study in the online edition of the Journal of Diabetes Science and Technology¹ presented the final results from a proof-of-concept study testing whether MBT's investigational drug, NM505, can improve the tolerability of metformin. NM505 is an orally-administered combination of metformin and some of the active ingredients contained in NM504, the company's lead microbiome modulator. Metformin is an effective, safe and inexpensive medication that is the preferred first-line treatment worldwide for Type 2 diabetes. However, metformin's gastrointestinal (GI) side effects such as diarrhea are a frequent cause of discontinuation or dosage limitation, with more than 40% of newly diagnosed patients estimated to discontinue metformin or combine it with another oral anti-diabetes drug in the first year of therapy.

In the double-blind, randomized, crossover study, a preliminary formulation of NM505 or a combination of metformin plus placebo was administered to patients with Type 2 diabetes who were metformin intolerant. Results showed that metformin tolerability was significantly increased in patients taking NM505, who reported less severe GI side effects and also showed improvements in fasting blood glucose levels compared to patients receiving the metformin-placebo combination. MBT is currently planning to conduct a larger clinical trial of NM505 that could allow the company to seek FDA marketing approval via the expedited 505(b)(2) regulatory pathway.

Second, the company reported that it recently received a notice of allowance from the US Patent and Trademark Office (PTO) for its fast track patent application for microbiome modulator NM504 as a treatment for diabetes and obesity. In a double-blind, randomized, placebo-controlled clinical study presented at ICE/ENDO 2014, NM504 shifted the gut microflora of prediabetic and Type 2 diabetes patients in beneficial ways, significantly improving post-meal blood glucose and insulin levels.

Third, in a March, 2015 presentation at the National Meeting of the American Chemical Society (ACS), company researchers showed that MT303, a small molecule glyceollin microbiome modulator, stimulated greater microbiome diversity, reduced absorption of dietary fat and mediated changes that improved gastrointestinal function in obesity-prone mice.² The full study will be published in a peer-reviewed journal. Glyceollins are small molecule natural products made by soy plants to combat bacterial and fungal infections and other stressors. In animal studies, glyceollins have demonstrated activity in a number of human disease models, including metabolic disorders. Earlier this year, MBT reported that it had received a notice of allowance from the US PTO for a patent covering glyceollin as a potential treatment for diabetes and obesity.

"This is an exciting time for our company, with growing validation of the therapeutic potential of our novel microbiome modulators and mounting evidence that our lead compounds are indeed patentable," said Steve Orndorff, PhD, CEO of MicroBiome Therapeutics. "We are proud pioneers in the campaign to harness the rapidly growing understanding of the GI microbiome to improve human health, and look forward to sharing our progress with investors as we launch a series B equity financing to advance the clinical and regulatory development of our promising candidates."

1 - Addition of a Gastrointestinal Microbiome Modulator to Metformin Improves Metformin Tolerance and Fasting Glucose Levels, Jeffrey H. Burton, PhD, Matthew Johnson, BS, Jolene Johnson, MD, Daniel S. Hsia, MD, Frank L. Greenway, MD, and Mark L. Heiman, PhD, Journal of Diabetes Science and Technology, DOI: 10.1177/1932296815577425

2 - Chemical Library in Food Presents the Natural Ligands for the GI Microbiome, Mark Heiman, PhD, MEDI: Targeting the Microbiome, 249th ACS National Meeting, Denver, CO, March 22, 2015.

About MicroBiome Therapeutics

MicroBiome Therapeutics LLC (MBT) is a clinical stage biotechnology company developing drug therapies for metabolic diseases that aim to improve health status by altering microbial populations and their environment in the GI tract. MBT's microbiome modulators are designed to augment the growth of certain bacterial strains and discourage the growth of others. NM504 improved blood glucose levels in a clinical trial in prediabetes and Type 2 diabetes. NM505, a reformulation of metformin incorporating microbiome modulators to increase the tolerability and utility of this first-line diabetes therapy, has demonstrated positive results in a proof-of-concept clinical study. MT303, a small molecule glyceollin microbiome modulator, stimulates microbiome diversity, reduces absorption of fat and may improve GI function in obesity-prone mice. For more information, visit mbiome.com.