Furiex Pharma Says EXAMINE Trial Meets Primary Endpoints

(RTTNews) - Furiex Pharmaceuticals, Inc (FURX) Tuesday confirmed that Takeda Pharmaceutical Company Limited announced top line results of the EXAMINE (Examination of Cardiovascular Outcomes: Alogliptin vs. Standard of Care in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular safety outcomes trial showing the primary endpoint of non-inferiority compared to placebo in addition to standard of care was met with no increase in cardiovascular risk in a Type 2 diabetes patient population at high-risk for cardiovascular events.

"The EXAMINE trial is an important evaluation as it assesses cardiovascular safety in patients known to be at high risk for cardiovascular disease," said June Almenoff, president and chief medical officer of Furiex. "Cardiovascular disease is very common in patients with Type 2 diabetes and the results of this study provide clinicians with assurance that alogliptin is effective and well-tolerated in these patients, and does not adversely affect cardiovascular health outcomes."

The principal secondary safety endpoint was the primary composite with the addition of hospitalization for unstable angina that required coronary revascularization within 24 hours of hospital admission. Other secondary endpoints included cardiovascular death alone and death from any cause.Additional safety end points included angioedema, hypoglycemia, pancreatitis, malignancy and results of laboratory testing, the company said.