Patients will receive Adipotide as an injection under the skin once daily for 28 days. Up to five-dose levels will be tested with three participants enrolled at each dose level. The first group will receive the lowest dose and each new group will receive a higher dose level than the group before it, based on an evaluation of observed safety. This will continue until the highest dose of Adipotide with acceptable safety is found or all five dosing cohorts have been completed.
"We are delighted to announce that patient dosing has begun in the Phase 1 trial of Adipotide," said Dr. Chris Anzalone, president and chief executive officer of Arrowhead. "Obesity and its related co-morbidities represent a serious public health issue in the United States and other parts of the world. We believe Adipotide is a promising pharmacological option to combat it. Through our unique approach of acting directly on the vasculature of fat rather than the brain, we hope to avoid the many safety concerns that have hindered other anti-obesity drug candidates. Moreover, the preclinical efficacy we have seen is striking and we are eager to see results from this first-in-man study."
Multiple independent studies with Adipotide have demonstrated that obese rodents lose up to 30 percent of their body weight after only 28 days of treatment while lean animals show no weight loss. Studies have also shown that obese animals undergo rapid improvement in pro-diabetic metabolic markers, including significantly improved insulin sensitivity, improved glucose tolerance, and a reduction in serum triglycerides after only two to three days of treatment. Adipotide has been further studied in non-human primates, and it has been reported that after 28 days of treatment obese rhesus monkeys lost an average of 11 percent of their body weight, experienced a reduction in body mass index and abdominal circumference, and showed marked improvements in insulin resistance, a marker for type II diabetes. These data were published in the peer-reviewed journal Science Translational Medicine in November 2011.