Zafgen Announces Additional Weight Loss and Cardiometabolic Data from Phase 1 Studies of Beloranib in Obesity at American Diabetes Association's 72nd Scientific Sessions®
Results Show Treatment with Beloranib Resulted in Weight Loss and Corresponding Reductions in Multiple Cardiometabolic Risk Factors in Severely Obese Subjects
(PressMethod) - Zafgen, Inc., the world's first biopharmaceutical company dedicated to addressing the unmet need of severely obese patients, today announced new data from two Phase 1 studies of beloranib, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed significant weight loss and improvements in cardiometabolic risk markers in severely obese women. Treatment with beloranib was associated with improvements in weight loss and triglycerides, LDL cholesterol, waist circumference and diastolic blood pressure, with no evidence of major tolerability or safety issues. Body composition measured in one study indicated a reduction in fat mass with beloranib. The data will be presented in a poster session at the American Diabetes Association's 72nd Annual Scientific Sessions in Philadelphia on June 10th at noon EDT.
Beloranib, a novel obesity therapy that utilizes a unique mechanism of action, is being studied for its ability to restore balance to the production and utilization of fat. The Phase 1 trials were randomized, double-blind, placebo-controlled studies to evaluate the safety, tolerability and efficacy of twice-weekly intravenously administered beloranib in severely obese women with a body mass index (BMI) of 39.1 plus or minus 3.7 BMI kg/m2. Individuals received 0.9 mg/m(2), 3 or 6 mg beloranib (beloranib N=17) or placebo (N=11) twice weekly over a 25-day period (7 doses). Patients were allowed to eat normally and were not counseled to change their exercise habits. The trial enrolled 34 subjects of which 28 completed the study.
After 25 days of treatment, subjects treated with beloranib had lost significantly more weight (mean plus or minus SE: 4.3 plus or minus 0.4 kg; p<0.001, paired t test for change from baseline) versus the group that received placebo (-0.6 plus or minus 0.5 kg, NS).
Additionally, subjects treated with beloranib showed improvements in cardiometabolic risk factors including reduced triglycerides (mean plus or minus SE: -34.4 plus or minus 8.8 mg/dL), LDL cholesterol (-34.1 plus or minus 8.0 mg/dL), waist circumference (3.9 plus or minus 0.9 cm), and diastolic blood pressure (-4.5 plus or minus 2.1 mmHg; all p<0.05, paired t test for change from baseline), and C-reactive protein (-64%, p<0.001) whereas there was no change with placebo.
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