LivingMedicine/Drugs

Taking A Bite Out Of Carbohydrates

Treating diabetes traditionally has focused on lowering elevated levels of glucose in the bloodstream through diet and exercise, in addition to medications. Although Type 2s are the target of most diet and exercise advice, any Type 1 is aware that the less you demand of injected insulin’s glucose-lowering power, the better off you will be in the long run. Right after you learn to give yourself a shot, or how to check your glucose, your diabetes educator probably introduced you to the wonderful world of carbohydrate counting and control. Wasn’t it just yesterday that I, or my child, could eat all the bread we wanted? No more, at least without elevated glucose consequences.

You may also have learned about the glycemic index, which assigns a numeric value to each gram of available carbohydrates from food (total carbohydrates minus fiber) and its effect in raising blood glucose. The glycemic index is a tool – at least in theory – that helps people manage the quality of their carb intake, not just the quantity. People can do that by calculating the glycemic load, which results from multiplying the index number for a food, lima beans, for example, by the total number of carbs in the actual serving size.

If trying to figure out the glycemic load of various foods has you scratching your head, or you just haven’t bothered, some potential good news is at hand. In the not-too-distant future, it may be possible to take a chewable tablet to lower the glycemic effects of any food, while simultaneously making you feel more full, so that you eat less. The drug in question, PAZ320, doesn’t yet have a sexy name, but its effects in human trials are striking enough to soon command some marketing guru’s attention.

An Accidental Tourist

PAZ320 inhibits the amount of sugar that can enter the bloodstream after eating, thus eliminating, or blocking, part of the root cause of the diabetes dilemma. In a larger context, the effects of PAZ320 may help reduce the effects of over-sugared diets found in North America among both diabetics and non-diabetics, thus helping to reduce weight gain, and potentially, obesity.

Following the logic of the last sentence, PAZ320 could claim about half of the people in the U.S. as a potential market. For now, let’s focus on the potential benefits to 25 million people with diabetes, the market most directly affected by Dr. David Platt’s new molecule.

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Dr. David Platt has three previous biopharma company launches to his credit.

Platt, a PhD who is an expert in carbohydrate chemistry, has founded three publicly traded companies prior to his current venture, Boston Therapeutics (www.bostonti.com), which owns the PAZ320 patents. His latest venture didn’t set out to affect people with diabetes, instead focusing on the larger issue of weight gain due to over-consumption of sugars in both the U.S. and a good portion of the developed world. PAZ320, his “better mousetrap,” is based on the natural ability of mannan, a polysaccharide that naturally occurs in the walls of various plants such as the ivory nut or carob bean, to slow down or block glucose conversion and release.

Here’s the definition: PAZ320 is a non-systemic, chewable drug that inhibits carbohydrate hydrolyzing enzymes. This means that PAZ320 doesn’t affect the entire body, just enzymes that break down complex sugars found in foods. PAZ320 gets between the enzymes and the food, allowing fewer of the complex sugars to break down into simple sugars. The result is that less sugar from carbs is converted into glucose, resulting in a lower glycemic effect, or less of a glucose “spike” after eating.

You could see this as a “Get Out Of Jail Free:” card, allowing you to eat what you like, regardless of the glycemic load of the food consumed. But, assuming that you don’t decide to use PAZ320 to enable gorging yourself on ice cream after every meal, reducing the rise in glucose levels will lower the levels of glucose that diabetes medications such as insulin have to deal with. Therefore, the dosage of such drugs may be reduced. Less insulin on board may reduce the risk of hypoglycemic events. So far, using PAZ320 looks like a “win-win” proposition, particularly for insulin users, although the initial target market for the drug is Type 2s.

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A slide from a Boston Therapeutics presentation demonstrates the action of PAZ320 in the body.

Lowering PPG

 PAZ320’s effects on PPG, or post-prandial glucose, was tested during 2012 on 24 people with diabetes, all Type 2s, who used various medications, including insulin, as part of their therapy. The study, conducted at Dartmouth’s Hitchcock Medical Center in Hanover, N.H. gave all of the trial subjects 75 grams of jasmine rice, a food with a high glycemic load because it breaks down quickly once inside the body.

The effects of both a low (8g) or high (16g) dose of PAZ320 were tested on all of the subjects. 45% of those who took the high dose (16g) of PAZ320 showed a 40% reduction in post-meal glucose levels as measured by a Continue Glucose Monitoring (CGM) over a 3-hour period. The drug only produces its effects when it has food to deal with. In studies so far, there has been no discernible effect on the efficacy of diabetes meds, and no significant hypoglycemic events. GI effects were mild. The company expects a full report of the Clinical Trial to be published in Endocrine Practice, a leading professional journal during the third quarter of 2013.

A Phase II study similar to the Dartmouth Hitchcock trial has been approved and is being organized in France. A Phase III trial, testing the effects of PAZ320 alone on A1c levels in Type 2 patients, after diet and exercise that have failed to lower their A1c with Metformin, is expected to begin in 2014 at a major U.S. diabetes clinic and in similar locations in Hong Kong, South Korea, and China.

 PAZ320 is just one example of many new approaches to diabetes treatment from scientists in disciplines such as food science. Understanding more about how both our digestive and endocrine systems work from a chemical and biological perspective is continually revealing new possibilities for more effective glucose control. While none of these solutions so far approaches a cure, the promise of more effective treatment of diabetes, while reducing the need for traditional medications, makes the future seem brighter for those affected.

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