Nastech Pharmaceutical Company Inc. has reported positive results from a dose ranging study designed to evaluate the pharmacokinetic parameters, appetite, food intake and safety of various doses of Nastech's proprietary PYY(3-36) nasal spray in obese subjects. The study identified doses for a long-term phase 2 efficacy and safety clinical trial.
The study was a double blind, cross over clinical trial of multiple doses of PYY(3-36) nasal spray in 24 obese subjects with a Body Mass Index of 30-40 kg/m(2). The study included intravenous (IV) PYY and placebo treatment arms. The purpose of the intravenous arms was to confirm the pharmacodynamics of IV PYY, which in three prior publications demonstrated an approximate 30 per cent reduction of caloric intake at the following meal. Subjects were randomized to each treatment arm with approximately one week between treatments.
"We are pleased with the study results showing that PYY nasal spray can reduce caloric intake as well as confirming the studies demonstrating calorie reduction with IV PYY," stated Steven C. Quay, M.D., Ph D, chairman, president and CEO of Nastech. "These results support a decision to advance this program toward a long-term phase 2 weight loss clinical trial. With obesity reaching epidemic levels worldwide, the need for a safe and effective product that promotes weight loss has become critically important."
Peptide YY is a naturally occurring hormone that is believed to function as a physiologic inhibitor of food intake. PYY is released into the blood stream from specialized endocrine cells (L-cells) in the gut after a meal and is believed to trigger the feeling of satiety, or fullness. Because PYY is a peptide, initial studies focused on PYY delivery by injection. Utilizing its proprietary drug delivery technology, Nastech developed the nasal spray formulation of PYY as a unique, non-invasive treatment option for obesity.
There are approximately 1.6 billion overweight adults worldwide, 400 million of whom are clinically obese according to World Health Organization. Obesity contributes to increased risk for chronic diseases including type 2 diabetes, cardiovascular disease and hypertension. PYY nasal spray may offer a novel treatment option for those suffering from this condition.
Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions.