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|Vitae Pharmaceuticals Announces Top-Line Results From Metformin Arm of Ongoing Phase 2 Clinical Trial of BI187004/VTP-34072 in Overweight Type 2 Diabetics|
Safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BI187004/VTP-34072 as monotherapy or as an add-on to metformin background therapy are being investigated over 28 days in a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Primary efficacy data (fasting plasma glucose) from the metformin arm did not meet Boehringer Ingelheim's predefined endpoint criteria. Data from the placebo-controlled monotherapy arm of the trial, which is still ongoing, are expected to be reported later this year. Together, these data sets will be used by Boehringer Ingelheim to determine appropriate next steps for BI187004/VTP-34072.
"The metabolically complex, overweight type 2 diabetic patient population is in need of novel mechanisms of action that can address their overall risk profile," said Dr.
About Type 2 Diabetes
Type 2 diabetes is a common and increasingly prevalent disease. According to the
BI187004/VTP-34072 is an 11β HSD1 inhibitor that was discovered using Vitae's proprietary Contour® platform and is being developed by Boehringer Ingelheim. BI187004/VTP-34072 is being studied for the treatment of type 2 diabetes and metabolic syndrome, and is Vitae's most advanced product candidate. In preclinical studies, BI187004/VTP-34072 had a positive impact on multiple cardiovascular and metabolic risk factors associated with metabolic syndrome, which differentiates it from other classes of type 2 diabetes drugs. BI187004/VTP-34072 is currently being studied in an ongoing Phase 2 proof-of-concept trial assessing efficacy and tolerability in diabetic patients on stable doses of metformin and as monotherapy.
For additional information, please visit the company's website at www.vitaepharma.com.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the clinical development of VTP-34072. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "target," "design," "estimate," "predict," "potential," "plan," "impending" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vitae is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vitae's forward-looking statements include, among others, the timing and success of preclinical studies and clinical trials conducted by Vitae and its collaborative partners; the ability to obtain and maintain regulatory approval of Vitae's product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitae's product candidates; the size and growth of the potential markets for Vitae's product candidates and the ability to serve those markets; Vitae's expectations regarding Vitae's expenses and revenue, the sufficiency of Vitae's cash resources and needs for additional financing; Vitae's ability to attract or retain key personnel; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vitae's Annual Report on Form 10-K for the year ended