The placebo-controlled trial, which enrolled 42 subjects, evaluated 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.
Top-line results, which were statistically significant as measured by an oral glucose tolerance test, demonstrated that twice-daily oral administration of NM504 reduced postprandial serum glucose levels and increased insulin sensitivity in these subjects.
Microbiome Therapeutics’ microbiome modulator also decreased markers of chronic inflammation and blood lipids in treated subjects, and it decreased appetite as determined by a validated physician- administered scale.
According to the company, the drug was well tolerated and patient compliance was excellent.
The company designed microbiome modulator to improve glucose tolerance and other metabolic parameters in patients with diabetes by shifting the gastrointestinal microbiome. NM504 is formulated to promote microbiome shifts that positively affect metabolism and weight.
Microbiome Therapeutics CEO Steve Orndorff noted this trial represents a milestone both for MBT and the emerging field of microbiome therapy.
"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," Orndorff added.
Currently, the microbiome modulator is also being studied in a double-blinded, proof of concept trial testing its utility in combination with metformin in type 2 diabetes patients with adverse GI effects.