Vitae Pharmaceuticals Reports Top-Line Results From Remaining Monotherapy Arm of Phase 2 Clinical Trial of BI187004 in Overweight Type 2 Diabetes Patients

Vitae Pharmaceuticals, Inc. VTAE, a clinical-stage biotechnology company, today announced top-line clinical efficacy results from the remaining monotherapy arm of Boehringer Ingelheim's Phase 2 proof-of-concept trial of BI187004 (VTP-34072) in type 2 diabetes. This randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial assessed the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BI187004 as monotherapy and as an add-on to metformin background therapy over a period of 28 days in patients with type 2 diabetes mellitus. In June 2015, Vitae reported that top-line results from the metformin arm of the Phase 2 trial did not meet the predefined primary efficacy endpoint criteria (fasting glucose lowering). As Vitae anticipated based on these earlier results, in this remaining monotherapy arm of the trial, BI187004 did not achieve the predefined primary efficacy endpoint criteria. As a result, Boehringer Ingelheim has informed Vitae of its intention to terminate the program and its corresponding license agreement. Vitae has no current plans to continue the program independently, but will assess options during the coming months.