Positive top-line results from Phenomix' Phase 3 trial of dutogliptin for Type 2 diabetes mellitus

Phenomix Corporation today announced positive top-line results from a six-month Phase 3 study comparing dutogliptin 400mg and 200mg once daily as monotherapy versus placebo for the treatment of patients with Type 2 diabetes mellitus. Dutogliptin is Phenomix' internally-discovered dipeptidyl peptidase-4 (DPP-4) inhibitor.

“We are very pleased with the results of this successful Phase 3 trial with dutogliptin. These results suggest that dutogliptin will provide clinically important glycemic control with potential improvements in tolerability in patients with Type 2 diabetes”

In this study, patients with moderately elevated baseline hemoglobin A1c (HbA_1c) levels (mean: 8.19%) treated with dutogliptin showed statistically significant reductions of HbA_1c versus placebo at week 24, the primary endpoint of the study. Reductions in HbA_1c corrected for placebo effects were 0.59% for the 400mg dose (p<0.0001) and 0.28% for the 200mg dose (p<0.0138). The results are similar to published data from trials evaluating other drugs from the DPP-4 inhibitor class.

Statistical significance was observed at the 400mg dose for all secondary endpoints, which included change from baseline in fasting and peak postprandial plasma glucose, change from baseline in glucose AUC (0-2 hours) after a standard test meal, and percentage of subjects reaching treatment goal of HbA_1c of less than 7.0%. Additional ongoing Phase 3 studies are evaluating the safety and efficacy of dutogliptin utilizing the 400mg dose in combination with metformin, sulfonylurea and pioglitazone.

In this monotherapy Phase 3 study, dutogliptin was well tolerated. The percentages of subjects reporting adverse events, discontinuing due to adverse events and reporting serious adverse events were similar in the dutogliptin and placebo groups. The table below lists the adverse events reported with a frequency of greater than or equal to 2% in any treatment group.

"We are very pleased with the results of this successful Phase 3 trial with dutogliptin. These results suggest that dutogliptin will provide clinically important glycemic control with potential improvements in tolerability in patients with Type 2 diabetes," said Laura K. Shawver, Ph.D., Chief Executive Officer of Phenomix Corporation.

Forest Laboratories today announced its decision to terminate its collaboration with Phenomix for the development and commercialization of dutogliptin for business reasons. "We are disappointed that on the heels of such positive Phase 3 data that we will not be moving forward with our collaboration with Forest. We expect to be talking to new prospective partners soon," added Dr. Shawver.

These top-line results are consistent with previously announced positive findings from a 12-week, Phase 2b study in which dutogliptin met all primary and secondary endpoints, including statistically significant reductions in HbA_1c when administered once daily in combination with metformin, a glitazone, or metformin and a glitazone for the treatment of Type 2 diabetes. In the Phase 2b trial, dutogliptin was well tolerated. The results were recently published in Diabetes, Obesity and Metabolism.