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Phase 2 Clinical Trial for Type 2 Diabetes Drug Candidate Shows Promise

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Phase 2 Clinical Trial for Type 2 Diabetes Drug Candidate Shows Promise
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Transition Therapeutics Inc. recently announced in a press release positive results in the Phase 2 clinical trial assessing the company’s drug candidate TT401 for the treatment of type 2 diabetes. The results will be submitted for presentation at a future medical meeting.

Transition Therapeutics is a biopharma developing novel therapeutics for central nervous system (CNS) and metabolic disorders. The company’s lead drug candidate, TT401, was developed for the treatment of type 2 diabetes and accompanying obesity, according to a press release.

In the trial, the first 12 weeks was a randomized, blinded stage, followed by 12 weeks of an open-label stage. TT401, a once-weekly oxyntomodulin analog with dual GLP-1 (glucagon-like peptide-1) and glucagon receptors agonist activity, was studied in 420 patients with type 2 diabetes, with a mean baseline Hb1Ac (glycated hemoglobin, a measure of the average blood sugar) of 8.2 percent, and a mean baseline weight of 203 pounds, or 92 kg. More than 90 percent of the subjects analyzed were on a stable dose of metformin at baseline.

The study was divided into four once-weekly dose arms of 10 mg, 15 mg, 30 mg and 50 mg of TT401, and a placebo arm and an active comparator arm – exenatide extended release (approved GLP-1 agonist for type 2 diabetes treatment), 2 mg.

The results showed that TT401 induced HbA1c improvements of a maximum of -1.43 percent (similar to the exenatide arm), and that the results of all TT401 dose arms and the exenatide arm were statistically significant in relation to placebo. TT401 was also observed to produce dose-dependent weight loss (a little above 3 kg). The weight loss observed in the highest dose arm (50 mg) was statistically significant in comparison to both the placebo and exenatide arms, at weeks 12 and 24.

In terms of safety, TT401 appeared to have an acceptable safety and tolerability profile, despite a series of treatment discontinuation and reports of serious adverse effects. The most frequently reported adverse events were of gastrointestinal nature, which were generally mild to moderate and decreased over time.

Eli Lilly and Company was an active collaborator in the development of this Phase 2 clinical trial. In March 2010, Transition Therapeutics licensed a number of pre-clinical compounds from Eli Lilly, including TT401. In June 2013, Eli Lilly chose to assume all development and commercialization rights of the drug. If its development is continued, Transition should be eligible to receive a milestone payment, as well as future royalties.

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