Nastech Pharmaceutical Company Inc. has submitted an Investigational New Drug (IND) application with the US Food and Drug Administration for PYY3-36 (PYY) nasal spray, the company's lead investigational product candidate for treatment of obesity. The filing of the IND precedes the initiation of clinical studies in the United States, stated a company release.
The study included in the IND is designed to evaluate the pharmacokinetic parameters, appetite, food intake and safety of various dosing regimens of PYY nasal spray in obese subjects. The objective of study is to determine the optimal dosing regimens that will be used to conduct a phase II clinical study based on the successful completion of this initial trial.
"We're moving aggressively to demonstrate the potential for PYY nasal spray to treat obesity," stated Steven C. Quay, M.D., Ph.D., chairman, president and CEO of Nastech. "We have been working with recognized experts in the obesity field to design the appropriate clinical trial program for this exciting candidate. Positive Phase II safety and efficacy data would be the basis for establishing a collaboration with a major pharmaceutical company for the remaining development and commercialization of PYY nasal spray."
Peptide YY is a naturally occurring hormone that is believed to function as a physiologic inhibitor of food intake. PYY is produced by specialized endocrine cells (L-cells) in the gut after a person eats and is believed to trigger the feeling of satiety, or fullness. Because PYY is a protein, 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 more than 1 billion overweight adults worldwide, 300 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.