Weight Loss Nasal Spray Begins Clinical Trials

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 percent reduction of caloric intake at the following meal. Subjects were randomized to each treatment arm with approximately one week between treatments. The trial results are:

-- PYY nasal spray produced a statistically significant treatment effect that varied with dose.
-- PYY nasal spray was well tolerated in this study, with side effects similar to previous studies.
-- IV PYY administered over 90 minutes produced a reduction in calorie intake similar to prior published study results.

"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.

Batterham RL, Cowley MA, Small CJ, Herzog H, Cohen MA, Dakin C, Wren AM, Brynes A, Low M, Ghatei M, Cone R & Bloom SR. Gut hormone PYY3-36 physiologically inhibits food intake. Nature. 2002, 418: 650-654.

Batterham RL, Cohen MA, Ellis SM, Le Roux CR, Withers DJ, Frost GS, Ghatei M and Bloom SR. Inhibition of food intake in obese subject by peptide YY3-36. The New England Journal of Medicine. 2003, 349: 941-948.

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