MicroBiome TherapeuticsTM LLC, (MBT) has announced positive top-line results from the company's clinical trial of lead microbiome modulator NM504 in development for type 2 diabetes and prediabetes. NM504 is designed to improve glucose tolerance and other metabolic parameters in patients with diabetes by shifting the gastrointestinal (GI) microbiome. Studies have shown that type 2 diabetics typically have GI dysbiosis, or microbial imbalances, that may contribute to the metabolic dysfunction associated with the condition.
The double-blind, randomized, placebo-controlled trial assessed whether NM504 administered for four weeks could improve the glucose tolerance of subjects with prediabetes and untreated type 2 diabetes by modulating the GI microbiome. The study enrolled 42 subjects.
Top-line results show that twice-daily oral administration of NM504 reduced postprandial serum glucose levels and increased insulin sensitivity in these subjects. The results were statistically significant as measured by an oral glucose tolerance test. NM504 also decreased markers of chronic inflammation and blood lipids in treated subjects, and it decreased appetite as determined by a validated physician-administered scale. NM504 was well tolerated and patient compliance was excellent.
"This trial represents a milestone both for MBT and the emerging field of microbiome therapy," noted Steve Orndorff, CEO of Microbiome Therapeutics. "NM504 is the first therapeutic shown to directly modulate the GI microbiome in diabetics, and this study is among the first randomized, placebo-controlled trials of a microbiome-based therapy to achieve a statistically significant medical outcome. We look forward to reporting more detailed data on this study at upcoming scientific meetings."
"The rising toll in morbidity, mortality and cost attributable to diabetes makes the need for novel therapeutic approaches urgent," said MBT Clinical Advisory Board member David D'Alessio, MD, Professor of Medicine at the University of Cincinnati College of Medicine. "Recent research suggests that the microbiome can be manipulated for therapeutic benefit, and modulators such as NM504 may offer an entirely new way to address diabetes. In this pilot study, NM504 significantly improved glucose tolerance in subjects with diabetes and prediabetes, and it was able to do so in the absence of any change in dietary habits. These promising data support additional trials to further assess the potential utility of NM504 in diabetes and prediabetes."
NM504 is also being studied in a placebo-controlled, double-blinded, proof of concept trial testing its utility in combination with metformin in type 2 diabetes patients with adverse GI effects. In a recently-published case study, NM504 demonstrated the potential to mitigate the GI side effects associated with metformin.
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.