Colorado-based MicroBiome Therapeutics (formerly known as NuMe Health) is also talking to pharmaceutical firms about using the ingredient - NM504 - as an adjunctive therapy for type 2 diabetics on the drug Metformin.
The firm, which has hired biotech entrepreneur Dr Steve Orndorff as its new CEO, claims NM504 can help people maintain healthy blood sugar levels by beneficially altering the balance of gut microflora, increasing Bacteriodetes microbiota and decreasing Firmicutes microbiota.
Its chief science officer is Dr Mark Heiman, a leading researcher in endocrinology and obesity, who has 20 years’ experience at Eli Lilly working on endocrine-related drug discovery and development.
Gut bacteria of people with type 2 diabetes is very different
Speaking to FoodNavigator-USA this week, Orndorff said that prediabetes is estimated to affect 79m Americans.
And while prediabetics are not as easy to reach as diagnosed diabetics, awareness is rising fast - not least because current methods of addressing the problem: being told to exercise more and lose weight - are not working, he said.
Meanwhile, 20% of people with type 2 diabetes are intolerant to Metformin, the drug typically prescribed after they are first diagnosed, he said.
Current methods of addressing prediabetes - being told to exercise more and lose weight - are not working
So the need for a safe, well-tolerated, but effective alternative is urgent, he said, with natural ingredients that alter the profile of the gut flora showing great promise.
“Research shows that the microbiome in people with type 2 diabetes is different in significant ways from that of healthy individuals.”
And rodent studies on NM504 - which contains a proprietary combination of fermentable prebiotic fiber, beta glucan and a berry extract - show it can beneficially alter the balance of gut microflora, increase insulin sensitivity, improve oral glucose tolerance test results, lower overnight fasting blood glucose levels and improve lipid profiles, he said.
We now have two human clinical trials underway
While several ingredients have individually been shown to help maintain healthy blood sugar levels, it was the combination of ingredients used in NM504 that made it special, he claimed.
“We now have two human clinical trials underway. The first - which is almost finished - is on 45 prediabetics and looks at blood glucose, insulin, hormones such as PYY and GLP-1, as well as the number and distribution of individual species of gut microflora using metagenomic analyses.
“The second trial is a crossover study on 10 diabetic patients who are intolerant to Metformin using NM504 as an adjunct therapy.”
'An exciting time to be a pioneer in the emerging field of microbiome modulators'
Asked why MBT was going down the medical foods and pharma route as opposed to functional foods or dietary supplements, he said: ”Medical foods have a much higher intrinsic value and market barriers than foods and supplements.”
As for product claims, he said:“We believe medical food products could be labeled as ‘for the dietary management of type 2 diabetes’.”
Elstrott (MBT’s co-founder and chairman) said:“The explosion of knowledge about the human microbiome makes this an exciting time to be a pioneer in the emerging field of microbiome modulators.”
Prediabetes - a ticking time bomb
According to the American Diabetes Association, prediabetes (elevated fasting blood glucose levels), is estimated to affect 79m or one in three American adults, and if unchecked, can lead to type 2 diabetes.
If current trends continue, says the charity, one in three American adults will have diabetes by 2050.