According to CEO Dale Pfost, the patent application by the company called MicroBiome Therapeutics covers the composition and use of its lead microbiome modulator candidate, which goes under the development name of NM504. The patent allowance covers NM504’s unique combination of ingredients as a human microbiome modulator for improving blood glucose regulation. Pfost said the allowance includes use of NM504 in diabetic patients and pre diabetics at risk of developing diabetes, and covers NM504 delivered in any format, including capsules, tablets, and food-like vehicles such as smoothies and nutrition bars.
The formulation has been under development for a number of years, Pfost said. The product, whose precise makeup is still under wraps pending the issuance of the patent, is a combination of prebiotics offering soluble fiber and a beta glucan which has immune boosting properties and acts as what Pfost called a ‘thickening agent.’
The formula also includes a polyphenol source that offers the benefits of antioxidant activity and capitalizes on the proliferation of recent research into the role of polyphenols in gut health. Pfost said when the company looked at the target activity it was seeking, nothing that was in the market really matched up.
“What we have found is that what we were looking for wasn’t actually commercially available. We worked with a major supplier and came up with what amounts to a proprietary berry extract,” Pfost told NutraIngredients-USA.
The inclusion of the polyphenols points to a key aspect of the formulation strategy. Pfost said the product developers were more interested in what different configurations of the gut microbiome could do, rather than trying to alter the head count of what species are present at what time. Many probiotic formulations base their claims of efficacy and mode of action on data that shows shifts in populations. In other words, Pfost said in effect it doesn’t matter so much who’s in the choir, but rather how they sound together.
“We stepped back from how to best influence the microbiota itself. We were looking more at the top level analytes, like blood glucose levels and the change in the production of short chain fatty acids,” he said.
The company has data showing the product’s effect on the modulation of blood glucose in susceptible populations. Its most recent study was conducted on patients being treated with the drug metformin that aims to control blood glucose levels in Type 2 diabetes. The study results showed that the metformin performed better when administered with NM504.
That information, while reinforcing efficacy and mode of action, won’t be of much help in developing a marketing plan for a dietary supplement, which is the first market the company is targeting with the formulation. The product (which will be renamed), is a lightly sweet powdered formula meant initially to be added to smoothies. But it speaks to the difficulty faced by all developers of gut health dietary supplement products, in that there is no regulatory definition of a ‘healthy’ gut, no biomarkers to point to, so researchers are left with nipping around the edges of diseased populations to see if they can demonstrate an effect for the dietary ingredients they are studying.
“We are very respectful of the regulatory categories. We do see the initial category for this product being as a supplement. The others we will consider are as a medical food, a straight food positioning, or as a pharmaceutical,” Pfost said.
“The claims palate for a supplement is somewhat constrained, but we are looking at claims like helps manage blood sugar, helps manage hunger, or helps manage GI health,” he said.