Transition Therapeutics/Lilly Begins Phase 2 Clinical Study of TT-223, With the Promise of Beta-Cell Regeneration

Transition Therapeutics Inc. announced that the first patient has been dosed in a Phase 2 clinical study of gastrin analogue, TT-223. The study is a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability and efficacy of daily TT-223 treatments for 12 weeks with a 6-month follow-up. Approximately 80 patients with type 2 diabetes are expected to be enrolled in the study and will receive a daily treatment of TT-223 in addition to their current regimen of oral glucose lowering agents (metformin and/or thiazolidinediones).Transition’s gastrin-based therapies offer a new hope and a chance to live a "normal" life for millions of diabetes patients who are dependent on daily insulin injections and strict diet regimens. They have the potential to reduce or eliminate the need for regular insulin injections for months or even years by regenerating the body’s own insulin-producing cells with a short-course treatment. The potential market size in the U.S. alone is estimated to be over US$16 billion.

Transition’s gastrin-based therapies culminate gastrin’s ability to regenerate the body’s own insulin-producing cells (islet beta cells in the pancreas). Gastrin can also synergize with other agents that can regulate blood glucose such as GLP-1 or DPP-IV inhibitors to correct hyperglycemia in diabetes patients.Transition and Eli Lilly and Company have entered into alicensing and collaboration agreement granting Lilly exclusive worldwide rights to develop and commercialize gastrin based therapies, including the lead compound TT-223. Gastrin based therapies are an emerging class of potential disease-modifying therapies for patients with diabetes, and have been shown to provide sustained improvement in glycemic control in preclinical models and early clinical studies. www.transitiontherapeutics.com

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FDA announces likely delay on Novo Nordisk’s incretin diabetes drug:  The Food and Drug Administration has announced that it will be unable to meet the user fee deadline for a timely approval of Novo Nordisk’s drug liraglutide. The FDA will not be able to make an approvability decision until March 23 for the drug, a treatment for Type 2 diabetes. Novo Nordisk had submitted an approval application for the drug on May 23.The standard review period for FDA action on approval applications is 10 months. Because the agency’s advisory committee meeting will take place shortly before March 23, however, its decision will probably be delayed by a further two months, the company said.