Innodia Inc Advances Lead Drug Candidate for Treatment of Type 2 Diabetes
Posted on: Wednesday, 6 April 2005, 15:00 CDT
MONTREAL, April 6 /PRNewswire/ -- Innodia Inc, a biopharmaceutical company engaged in bringing to market novel drugs for the treatment of type 2 diabetes and related diseases, announced today the initiation of a Phase Ib escalating multiple-dose human clinical trial with ID 1101, its lead drug candidate for the treatment of type 2 diabetes. The Company also announced positive safety results on the recently completed single-dose Phase Ia clinical trial with ID 1101.
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 hypoglycemia observed with the use of other insulin secretagogue agents. ID 1101 has been shown to be effective in several experimental models of diabetes with no evidence of toxicity. Toxicological studies with ID 1101 have also demonstrated a high safety margin.
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, such as ID 1101, are desperately needed to treat this serious disease.
"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 the Company. "We are very pleased to move the clinical development of ID 1101 further ahead with this Phase I multiple-dose trial. This trial will be followed by Phase II studies aiming at demonstrating efficacy in patients with type 2 diabetes," he added.
In the recently completed Phase Ia trial, ID 1101 given orally in escalating single-dose was well tolerated, showed an excellent safety profile along with dose-proportional pharmacokinetics. These results support the continuation of the clinical development.
Innodia has received regulatory approval from Health Canada to commence a multiple dose Phase 1b trial with ID 1101. The main objectives of the trial are to establish the safety, tolerability and pharmacokinetic profile of ID 1101 given in multiple doses for 14 days. The trial design is a randomized, 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.
According to the American Diabetes Association, an estimated 21 million Americans (7% of the U.S. population) have diabetes, with an additional 1.3 million new cases diagnosed every year. This is an expanding epidemic due to ageing of the population and the high prevalence of obesity. Diabetes is the fourth-leading cause of disease-related death in the United States. Similar disease incidence statistics are reported by the Canadian Diabetes Association.
Innodia Inc.
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Innodia is a privately held biopharmaceutical company engaged in bringing to market novel drugs for the treatment of diabetes and related diseases and in generating value for its shareholders. The Company portfolio includes 4 novel and complementary approaches to the treatment of type 2 diabetes acting on different molecular targets and at different stages of the disease. Diabetes continues to increase in prevalence around the world with more than 170 million people affected by the disease, according to the World Health Organization, a number that is expected to exceed 300 million by 2025. Most diabetics have type 2, or adult-onset diabetes.
Innodia Inc.
CONTACT: Claude Vezeau, Pharm.D., President & CEO, Innodia Inc., Tel:(450) 781-8818 ext. 2401, Fax: (450) 781-8819, cvezeau@innodia-inc.com,http://www.innodia-inc.com/
Source: PRNewswire
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