Nastech Pharmaceutical Company Inc. has announced the start of a phase II clinical trial evaluating the company's PYY3-36 nasal spray in obese patients.
According to a company press release, the study will enrol approximately 500 obese patients for a six-month, randomised, placebo-controlled dose ranging study with weight loss as the primary endpoint.
The phase II study design will evaluate three different doses of Nastech's PYY3-36 nasal spray compared to placebo and sibutramine (meridia), a commercially available oral weight loss drug, with the primary endpoint being weight loss. Patients in the active PYY treatment arms will take PYY3-36 nasal spray or nasal spray placebo three times daily prior to a meal over the 24-week period.
The study design will enable patients to undergo an initial dose optimisation period to establish an optimal dose to continue over the duration of the trial. Although the primary endpoint is weight loss the study will also evaluate other effects including comparing the proportion of patients who lose at least 5 per cent or 10 per cent of their baseline body weight as well as the effect on haemoglobin A1c (HbA1c) levels. Lowering HbA1c levels has been shown to delay or prevent problems associated with diabetes such as damage to the eyes, kidneys, and nerves. Screening of patients is in process and dosing is scheduled to begin this month.
"Nastech has developed a patient friendly, non-invasive nasal spray dosage form of a naturally occurring peptide, PYY, which in the body signals the brain that you have consumed sufficient calories and to therefore stop eating. The phase II trial that we are initiating is designed to demonstrate the effectiveness of PYY nasal spray in promoting weight loss which, if successful in development and approval, could help treat what has become an international health epidemic affecting hundreds of millions of people worldwide," said, Steven C. Quay, M.D., Ph.D., chairman, president and CEO, Nastech.
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, the press release said.