Existing therapies are limited in their ability to manage the disease effectively and physicians have expressed major concerns over side effects observed with current available treatments. Novel approaches are desperately needed to treat this serious disease.
The problem is particularly serious in the US, where there is an expanding epidemic due to ageing of the population and the high prevalence of obesity. According to the American Diabetes Association, an estimated 21 million Americans (7 per cent of the US population) have diabetes, with an additional 1.3 million new cases diagnosed every year.
Innodia has received regulatory approval from Health Canada to commence a multiple dose Phase 1b trial with ID 1101. The main objectives are to establish the safety, tolerability and pharmacokinetic profile of ID 1101 given in multiple doses for 14 days.
The trial design is a randomised, double-blind, placebo-controlled study to be performed in 36 healthy volunteers selected on the basis of parameters indicative of insulin resistance. The results will direct the design of planned Phase II efficacy trials in type 2 diabetes patients to start by the end of 2005.
Innodia have previously reported positive results after a single-dose Phase I trial, which has resulted in this latest multiple-dose Phase I Trial. ID 1101 has been shown to be effective in several experimental models of diabetes.
The drug candidate, which was given orally, was well tolerated and showed an excellent safety profile along with dose-proportional pharmacokinetics. These results support the continuation of the clinical development. In addition, toxicological studies with ID 1101 have so far demonstrated a high safety margin.
ID 1101 is an orally active antidiabetic drug candidate with a unique dual mode of action; it increases insulin secretion by the pancreas and decreases peripheral insulin resistance observed in type 2 diabetes. The increased insulin secretion activity is dependent on abnormally high blood glucose concentration, a characteristic that reduces the risk of hypoglycaemia observed with the use of other insulin secretagogue agents.
"We are very encouraged by the successful results of our single-dose Phase I trial with ID 1101 which, we believe, holds real promise for patients," said Dr Claude Vezeau, president and CEO of Innodia.
"This trial will be followed by Phase II studies aiming at demonstrating efficacy in patients with type 2 diabetes," he added.
Type 2 diabetes, or adult onset diabetes, is typically an age-related metabolic disorder, although prevalence among children has been rising in recent years. Type 2 diabetes is characterised by a patient's inability to respond to insulin, a condition referred to as insulin resistance.
Consequently, the body produces elevated levels of insulin. Despite increased insulin production, as the disease progresses, the patient loses the ability to control blood glucose levels. While most patients are managed with oral therapy, in many patients, insulin supplements must be taken.
According to IMS data, the global market for oral diabetes treatments exceeded $4.5 billion in 2004. The global market for insulin approximated $3 billion in 2003. In the United States, the generic entry of Metformin has caused total revenues from the class to moderate to approximately the 6 per cent level in 2003, and total revenues from the class are expected to decline in 2004 by about 6 per cent, despite 5 per cent expected prescription growth, due to more generic entries, particularly in Bristol Myers Squibb's Glucophage class. The newest class, the glitizones, continue to grow.