Diabetes is a condition in which the body either does not produce enough or does not properly respond to insulin. Insulin, a hormone produced in the pancreas, enables cells to process glucose and turn it into energy. When the body fails to process glucose, it accumulates in the blood, leading to a condition known as hyperglycemia, which, if left unaddressed, can lead to serious complications, including kidney damage, neurological damage, cardiovascular damage, and loss of vision. Diabetes treatments aim to maintain blood glucose at a level as close to normal as possible, in order to avoid these serious long-term complications.
There are two major types of diabetes: Type 1 diabetes (previously referred to as juvenile or insulin-dependent diabetes), an autoimmune disease that destroys the body’s ability to produce natural insulin, and Type 2 diabetes (formerly referred to as adult-onset or non-insulin dependent diabetes), a condition that results from the body developing insulin resistance.
According to the American Diabetes Association, approximately 90% of Americans diagnosed with diabetes have Type 2 diabetes, resulting in an estimated U.S. population approaching 24 million, or almost 8% of the total population. In addition, it is estimated that there are approximately 57 million people in the U.S. with a condition known as ‘pre-diabetes,’ which occurs when glucose levels are higher than normal but not yet high enough for a diagnosis of Type 2 diabetes.
Although Type 2 diabetes is initially managed by change in lifestyle, including increasing exercise, modifying diet and weight loss, medications are typically needed as the disease progresses. Despite the many treatments currently available, it is estimated that glucose levels in more than half of the U.S. population are not properly controlled. Market research suggests this lack of control most likely due to poor patient compliance and the lack of potency of marketed therapeutics. Risk of hypoglycemia, or too low blood sugar, from overuse of medicines combined with high rates of adverse events have also been blamed for poor patient compliance and reduced physician prescriptions.
Market research has indicated that physicians readily accept new diabetes treatments that demonstrate even a small benefit in efficacy if they are proven to be safer. Early clinical work on BSN175 indicates that the candidate may have several characteristics that, if approved, would be viewed favorably by the market, including:
- No evidence of hypoglycemia,
- Oral availability via a variety of formulations,
- Indications of appetite suppressant effects, and
- Demonstrated ability to lower blood glucose as measure by HbA1c.