As Big Pharma Deals with Diabetes Drug Toxicity, Small Company Seeks Safer Path

Manchester, NH-based company developing non-systemic, non-toxic complex carbohydrate-based new chemical entity codenamed "PAZ320" to lower post-meal elevation of blood glucose.

These are frustrating times for several Big Pharma companies with diabetes drugs. The U.S. Food and Drug Administration is currently considering whether to run a study to determine if a definitive link can be established between some drugs marketed by Merck, Bristol-Myers-Squibb, AstraZeneca, Eli Lilly and Novo Nordisk, and reports of acute pancreatitis and pancreatic cancer. All the drugs in question mimic a hormone called GLP-1 to stimulate natural insulin production. In a separate case, another drug, marketed by GlaxoSmithKline, has lately been potentially linked to cardiovascular risks.

While this drama is unfolding, a smaller player in the diabetes market is making strides with an alternative approach involving complex carbohydrate chemistry. Carbohydrate chemistry can be applied to develop a range of complex therapeutic molecules and drugs, including pure carbohydrates as well as protein-linked carbohydrates. However, as a consequence of their structural complexity, carbohydrates have not received as much scientific attention as nucleic acids and proteins. However, significant progress is being made in this area.

Manchester, NH-based Boston Therapeutics is developing a non-systemic, non-toxic complex carbohydrate-based new chemical entity codenamed PAZ320 for its ability to lower post-meal elevation of blood glucose, and thus as a treatment to delay or prevent the onset of Type 2 diabetes and related complications such as heart disease, stroke, kidney damage, retinopathy and diabetic foot. The chewable tablet is a complex polysaccharide to be taken before meals; it operates in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbs in foods during digestion, lowering the amount of available glucose absorbed via the intestine.

A recent study evaluated the combination of PAZ320 and oral agents or insulin in 20 patients with Type 2 diabetes between the ages of 18 and 75 with a body mass index of 25-40 kg/m2 and with HbA1c of less than or equal to nine percent. HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous three months. Forty-five percent of patients responded with a 40 percent reduction of post-meal glucose in the blood compared to baseline in a dose-dependent manner. Additionally, results showed the effect of PAZ320 does not correlate with duration of diabetes and works regardless of concurrent diabetes medications.

For more information, please visit www.bostonti.com.

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