Monday, Transition Therapeutics Inc. (TTHI,TTH.TO) announced positive results from a Phase 2 clinical study of gastrin analogue, TT-223, in patients with type 2 diabetes.
Diabetes mellitus type 2 or type 2 diabetes, is a disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. In type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary for the body to be able to use glucose for energy.
The Canadian biopharmaceutical company stated that patients who received highest daily dose of TT-223 for 12 weeks and completed the entire study without adjusting their diabetes therapies experienced a statistically significant reduction in HbA1c of 1.13%, in six months post treatment. This compares with placebo treated patients, who experienced a 0.22% HbA1c reduction in 6 months post-treatment. HbA1c is a reflection of a person's average glucose level and is used by doctors as a measure of glucose management.
To evaluate the safety, tolerability and efficacy of once-daily subcutaneous injections of TT-223, a randomized, double-blind, placebo-controlled, dose-ranging study was conducted, enrolling type 2 diabetes patients who were unable to achieve adequate glucose control. The once-daily dose of TT-223 was titrated as tolerated to the maximum dose during the first three weeks, and patients remained on the highest tolerated dose for the remaining nine weeks of the treatment period. The two stage study consisted of a 12-week treatment period and a 6-month follow-up period. Patients continued their current background diabetes therapy through both stages.
The company informed that there were no treatment-related serious adverse events. Post prandial and AUC, or area under the curve, glucose showed improvement versus placebo but not against baseline at 3 and 6 months post-treatment. Fasting blood glucose and mixed meal tolerance insulin parameter tests did not show improvement. No detectable changes in weight were observed.
Eli Lilly and Co. (LLY) holds the exclusive worldwide rights to develop and commercialize Transition's gastrin based therapies. Under the terms of the agreement inked in March 2008, Transition has received a $7 million upfront payment, and may also receive up to $130 million in potential development and sales milestones, as well as royalties on sales of gastrin based therapies if any product is successfully commercialized.
Tony Cruz, chairman and chief executive of Transition said, "These data are very encouraging and supports the gastrin based approach. The progressive reduction in HbA1c levels six months after completion of treatment suggests potential disease-modifying properties of gastrin based therapies and differentiates them from other diabetes treatments."
Friday, TTHI closed regular trading at $3.37, on the Nasdaq and LLY closed regular trading at $35.52, on the NYSE.
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