“NM504 shifts the gut microflora from a state of dysbiosis to a normal state,” Steve Orndorff, Microbiome’s CEO, told NutraIngredients-USA.
NM504, which Microbiome Therapeutics (MBT) calls a ‘cobiotic,’ is a mixture of inulin, beta glucan a proprietary mix of antioxidants, primarily anthocyanins and polyphenols.
“It works in three ways. It shifts the makeup on of the gut microflora, it addresses part of the physical environmnet in the gut by altering viscosity and it addresses the chemical component by providing more antioxidants,” Orndorff said.
The double-blind, randomized, placebo-controlled trial (the results of which are being prepared for presentation at various scientific meetings and for publication, Orndorff said) 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.
Orndorff admitted that when talking about ‘shifting’ the makeup of the gut microflora, there is little agreement as to what the ideal makeup should be. Research has shown it differs from person to person and from culture to culture. But when it’s out of whack, the effects are obvious.
“I think there is a general agreement that there is a marked difference between a normal state and a dysbiosis state. There are differences from individual to individual, and I don’t think anyone claims there is an ‘ideal’ microbiome,” Orndorff said. “The key in our opinion is the metatbolic funciton of those concortia of organisms.”
Orndorff said recent research is pointing the direction of a different gut microbiome profiles in diabetic and obese patients. Whether these different profiles are causative or symptomatic is still a matter of debate, but Orndorff said is has been shown that transplanting bacteria from obese mice into thin ones will make the latter fat.
Medical food use
Orndorff said the company is aiming at the medical foods and pharmaceutical space, not dietary supplements or functional foods. The company has data showing the product’s beneficial effects for patients who are taking the diabetes drug metformin, for example.
FDA recent issued an updated draft guidance on the subject of medical foods which seems to preclude the formulation of medical foods for diabetes, as the agency believes these conditions can be managed by dietary modificaiton alone. Orndorff said MBT’s view is that the situation is still fluid.
“There were quite a few organizations that filed comments with the FDA and they address not only the regulatory aspects of medical foods but also FDA’s position vis-a-vis diabetes. It’s really unknown right now where that is going to stand and the end of the day,” he said.
“We believe that if you conduct studies to a high level of sophistication and robustness you going to get a favorable review from FDA. There are a lot of products in the marketplace today in the area of diabetes that have very skimpy data to justify their existence.
“We see this (the draft guidance) as a good thing. It’s going to clean up the marketplace and get rid of those products,” Orndorff said.
The company lined up $1.3 million in bridge financing late last year to go with a $1.5 million in series A financing completed earlier in 2013. The company expects to complete a round of series B financing this year.