FORT WASHINGTON, PA, USA I June 29, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced top-line clinical efficacy results from the metformin arm of an ongoing Phase 2 proof-of-concept clinical trial of BI187004/VTP-34072 in the treatment of overweight type 2 diabetic patients. BI187004/VTP-34072 is a potential first-in-class 11β-hydroxysteroid dehydrogenase type 1 (11β HSD1) inhibitor that was discovered by Vitae and is currently being developed by Boehringer Ingelheim GmbH (Boehringer Ingelheim), a leader in diabetes treatments and cardiometabolic research and development.
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. Richard Gregg, Chief Scientific Officer of Vitae. “We are anxious to learn more about BI187004/VTP-34072 when the study is completed and fully analyzed.”
About Type 2 Diabetes
Type 2 diabetes is a common and increasingly prevalent disease. According to the American Diabetes Association, in 2015, approximately 20 million Americans had a diagnosis of type 2 diabetes and another 7.7 million were undiagnosed and unaware that they had type 2 diabetes. If the present trends continue, as many as one in three American adults are expected to have type 2 diabetes by 2050. Overall, the economic cost of diagnosed type 2 diabetes in the United States was estimated to be $245 billion in 2012 and, of that, approximately $9.6 billion was spent on type 2 diabetes drugs. Patients with metabolic syndrome, which affects approximately 85 percent of patients with type 2 diabetes, are characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, while having decreased levels of HDL-C or “good cholesterol.”
About BI187004/VTP-34072
BI187004/VTP-34072 is an 11β HSD1 inhibitor that was discovered using Vitae’s proprietary Contour(R) 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.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including disclosed programs in diabetes, Alzheimer’s disease, autoimmune disorders, atopic dermatitis and acute coronary syndrome. This robust and growing portfolio of novel product candidates is generated internally by Contour(R), Vitae’s proprietary structure-based drug discovery platform.
SOURCE: Vitae Pharmaceuticals
Post Views: 23
FORT WASHINGTON, PA, USA I June 29, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced top-line clinical efficacy results from the metformin arm of an ongoing Phase 2 proof-of-concept clinical trial of BI187004/VTP-34072 in the treatment of overweight type 2 diabetic patients. BI187004/VTP-34072 is a potential first-in-class 11β-hydroxysteroid dehydrogenase type 1 (11β HSD1) inhibitor that was discovered by Vitae and is currently being developed by Boehringer Ingelheim GmbH (Boehringer Ingelheim), a leader in diabetes treatments and cardiometabolic research and development.
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. Richard Gregg, Chief Scientific Officer of Vitae. “We are anxious to learn more about BI187004/VTP-34072 when the study is completed and fully analyzed.”
About Type 2 Diabetes
Type 2 diabetes is a common and increasingly prevalent disease. According to the American Diabetes Association, in 2015, approximately 20 million Americans had a diagnosis of type 2 diabetes and another 7.7 million were undiagnosed and unaware that they had type 2 diabetes. If the present trends continue, as many as one in three American adults are expected to have type 2 diabetes by 2050. Overall, the economic cost of diagnosed type 2 diabetes in the United States was estimated to be $245 billion in 2012 and, of that, approximately $9.6 billion was spent on type 2 diabetes drugs. Patients with metabolic syndrome, which affects approximately 85 percent of patients with type 2 diabetes, are characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, while having decreased levels of HDL-C or “good cholesterol.”
About BI187004/VTP-34072
BI187004/VTP-34072 is an 11β HSD1 inhibitor that was discovered using Vitae’s proprietary Contour(R) 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.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including disclosed programs in diabetes, Alzheimer’s disease, autoimmune disorders, atopic dermatitis and acute coronary syndrome. This robust and growing portfolio of novel product candidates is generated internally by Contour(R), Vitae’s proprietary structure-based drug discovery platform.
SOURCE: Vitae Pharmaceuticals
Post Views: 23
