MicroBiome Therapeutics Receives Positive Response From FDA For Use Of Expedited Regulatory Pathway For Diabetes Drug NM505

BROOMFIELD, Colo., May 12, 2015 /PRNewswire/ -- MicroBiome Therapeutics^TM LLC, (MBT) today reported that the U.S. Food & Drug Administration (FDA) has responded positively to the company's pre-IND request to use the 505(b)(2) abbreviated regulatory pathway for development of lead product NM505. This pathway allows the use of existing safety and efficacy data on the drug's key active ingredient along with relevant data in the public domain to reduce the size, scope, timeline and cost of the clinical program required for FDA submission and review.

NM505 is a proprietary combination of an MBT microbiome modulator and metformin, the most widely prescribed first-line therapy worldwide for Type 2 diabetes. A recently-published, peer-reviewed proof-of-concept clinical study showed that NM505 improves the tolerability of metformin while further reducing blood glucose levels in patients with Type 2 diabetes.

MBT also announced that CEO Steve Orndorff will be resigning at the end of the month to head up a new biopharmaceutical venture close to his home. The company's Board of Directors has therefore decided to actively seek strategic alternatives for the firm, in addition to potentially pursuing the Series B financing that had been scheduled to get underway once a positive response was received from the FDA.  

To kick-off the process, Dr. Orndorff is presenting at the 1st Annual Translational Microbiome Conference in Boston on Friday, May 15, 2015 at 1:45pm ET. He also will be meeting with potential partners and investors during the conference on May 14 and 15. To schedule a meeting with Dr. Orndorff, please contact [email protected].

In addition, MBT is convening an informational conference call for interested qualified potential partners, acquirers and investors. The call is scheduled for Tuesday, May 19, 2015 at 4:00pm ET. For information about the conference call, please contact [email protected].

"Obtaining agreement from the FDA to use the 505(b)(2) expedited pathway for our lead product is a major milestone for MBT, enabling us to target a 2017 NDA filing for our improved version of metformin, the leading treatment worldwide for Type 2 diabetes," said John Elstrott, PhD, co-founder and Chairman of MicroBiome Therapeutics. "MBT is a pioneer with unique expertise in the design and development of microbiome therapeutics, with two successful clinical trials of our microbiome modulators already completed.  We believe our pipeline of proprietary compounds has significant clinical and commercial potential in both prescription and non-prescription applications. We are grateful to Steve Orndorff for his contributions in helping us advance the company to this juncture, and we wish him well in his new venture."

"The favorable FDA response expediting the NM505 development program is the latest in a series of positive developments in our three microbiome modulator programs," noted Dale Pfost, PhD, MBT co-founder and Director. "The imminent departure of our CEO mandates that we consider strategic options without delay to ensure the future of the company's growing expertise in leveraging the microbiome to advance human health, as well as its promising clinical and preclinical programs. We already have received expressions of potential interest from a diverse group of companies and investors and we look forward to moving forward with these discussions in the coming weeks."

About NM505
NM505 is an orally-administered combination of metformin and key active ingredients in MBT's microbiome modulator NM504. 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. More than 40% of newly diagnosed patients are estimated to discontinue the drug or combine it with another oral anti-diabetes drug in the first year of treatment, resulting in significantly higher costs and potential safety issues. In a 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. The FDA recently indicated that MBT can use the expedited 505(b)(2) pathway for regulatory submission and review of NM505 as a treatment for Type 2 diabetes.

About NM504
NM504 is a proprietary combination of plant-derived components designed to shift the gastrointestinal microbiome to correct the microbial imbalances associated with high blood glucose levels and unhealthy body weight in people with Type 2 diabetes and prediabetes. In a double-blind, randomized, placebo-controlled clinical study presented at ICE/ENDO 2014, NM504 significantly improved post-meal blood glucose and insulin levels in patients with both prediabetes and Type 2 diabetes. In addition, NM504 decreased cholesterol levels and markers of chronic inflammation. It was well tolerated with no drug-related adverse events. MBT recently reported it had received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for its fast track patent application for NM504 as a treatment for diabetes and obesity. NM504 is in development as a medical food or supplement.

About MT303
MT303 is a small molecule glyceollin microbiome modulator in preclinical development. In a recent presentation at the National Meeting of the American Chemical Society, MBT researchers showed that MT303 stimulated greater microbiome diversity, reduced absorption of dietary fat, and mediated changes that improved gastrointestinal function in obesity-prone mice. The full study will soon be published in a peer-reviewed journal. Glyceollins are small molecule secondary metabolites 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 U.S. PTO for a patent covering glyceollin as a potential treatment for diabetes and obesity.

About MicroBiome Therapeutics
MicroBiome Therapeutics LLC (MBT) is a clinical stage biotechnology company developing 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 improved GI function in obesity-prone mice. For more information, visit mbiome.com.

SOURCE MicroBiome Therapeutics LLC

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