–Data Presented at ADA Shows Microbiome Modulator-Metformin Combination NM505 Significantly Improves GI Tolerability and Blood Glucose Control versus Metformin Alone–
–U.S. Patent Issues for NM505 Combination of Metformin and MBT’s Microbiome Modulator–
–MBT Is Assessing Strategic Alternatives for the Company and Its Programs–
NEW ORLEANS, LA, USA I June 9, 2015 I MicroBiome Therapeutics™ LLC, (MBT) today announced that positive clinical data on NM 505, a combination of a proprietary microbiome modulator and metformin, was presented at the 75th Scientific Sessions of the American Diabetes Association. Separately, the company announced that a U.S. patent has issued for its microbiome modulator-metformin combination NM505.
Data from a double-blind, randomized, crossover study presented at the ADA Sessions showed metformin tolerability was significantly increased in Type 2 diabetes patients taking NM505, who reported less severe GI side effects and achieved statistically significant improvements in blood glucose levels compared to patients receiving a metformin-placebo combination. The U.S. Food & Drug Administration recently agreed that MBT could file an NDA for NM505 for the treatment of Type 2 diabetes via the expedited 505(b)(2) regulatory pathway.
MBT also reported that it has received notice from the U.S. Patent and Trademark Office that Patent No. 9,040,101 has issued for the combination of metformin and MBT’s microbiome modulator that comprise NM505.
“The combination of rapidly growing healthcare interest in leveraging the human microbiome and the continuing good news reinforcing the potential of our lead microbiome modulator programs are encouraging as we consider strategic alternatives to secure the future of both the Rx and non-Rx parts of our business,” said Dale Pfost, PhD, co-founder and Director of MBT. “NM505 is attracting increasing attention as a potentially safe, efficacious and cost effective option for the millions of diabetes patients who cannot fully benefit from metformin, and it now has the added protection of an issued U.S. patent. NM504 has demonstrated improved blood glucose levels in a clinical trial in prediabetes and Type 2 diabetes and may have utility in applications for these large and growing populations.”
About MicroBiome Therapeutics
MicroBiome Therapeutics LLC (MBT) is a biotechnology company developing drug therapies for metabolic diseases that aim to improve health 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 efficacy of this first-line diabetes therapy, has demonstrated positive results in a proof-of-concept clinical study. MT303, a soy pod preparation containing 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, or contact gertrudepfost@gmail.com.
SOURCE: MicroBiome Therapeutics
Post Views: 27
–Data Presented at ADA Shows Microbiome Modulator-Metformin Combination NM505 Significantly Improves GI Tolerability and Blood Glucose Control versus Metformin Alone–
–U.S. Patent Issues for NM505 Combination of Metformin and MBT’s Microbiome Modulator–
–MBT Is Assessing Strategic Alternatives for the Company and Its Programs–
NEW ORLEANS, LA, USA I June 9, 2015 I MicroBiome Therapeutics™ LLC, (MBT) today announced that positive clinical data on NM 505, a combination of a proprietary microbiome modulator and metformin, was presented at the 75th Scientific Sessions of the American Diabetes Association. Separately, the company announced that a U.S. patent has issued for its microbiome modulator-metformin combination NM505.
Data from a double-blind, randomized, crossover study presented at the ADA Sessions showed metformin tolerability was significantly increased in Type 2 diabetes patients taking NM505, who reported less severe GI side effects and achieved statistically significant improvements in blood glucose levels compared to patients receiving a metformin-placebo combination. The U.S. Food & Drug Administration recently agreed that MBT could file an NDA for NM505 for the treatment of Type 2 diabetes via the expedited 505(b)(2) regulatory pathway.
MBT also reported that it has received notice from the U.S. Patent and Trademark Office that Patent No. 9,040,101 has issued for the combination of metformin and MBT’s microbiome modulator that comprise NM505.
“The combination of rapidly growing healthcare interest in leveraging the human microbiome and the continuing good news reinforcing the potential of our lead microbiome modulator programs are encouraging as we consider strategic alternatives to secure the future of both the Rx and non-Rx parts of our business,” said Dale Pfost, PhD, co-founder and Director of MBT. “NM505 is attracting increasing attention as a potentially safe, efficacious and cost effective option for the millions of diabetes patients who cannot fully benefit from metformin, and it now has the added protection of an issued U.S. patent. NM504 has demonstrated improved blood glucose levels in a clinical trial in prediabetes and Type 2 diabetes and may have utility in applications for these large and growing populations.”
About MicroBiome Therapeutics
MicroBiome Therapeutics LLC (MBT) is a biotechnology company developing drug therapies for metabolic diseases that aim to improve health 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 efficacy of this first-line diabetes therapy, has demonstrated positive results in a proof-of-concept clinical study. MT303, a soy pod preparation containing 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, or contact gertrudepfost@gmail.com.
SOURCE: MicroBiome Therapeutics
Post Views: 27
