Nastech Pharmaceutical Company Announces Initiation of Phase 2 Clinical Trial for PYY3-36 Nasal Spray to Treat Obesity
- Category: Proteins and Peptides
- Published on Tuesday, 02 October 2007 04:00
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BOTHELL, WA, USA | October 1, 2007 | Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today the start of a Phase 2 clinical trial evaluating the Company's PYY3-36 Nasal Spray in obese patients. The study will enroll approximately 500 obese patients for a six-month, randomized, placebo-controlled dose ranging study with weight loss as the primary endpoint.
The Phase 2 study design will evaluate three different doses of Nastech's PYY3-36 Nasal Spray compared to placebo and sibutramine (Meridia(R)), 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 optimization 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 % or 10 % of their baseline body weight as well as the effect on hemoglobin 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. More details are available at www.clinicaltrials.gov.
"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," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "The Phase 2 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."
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 biopharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and our collaboration partners are developing products for multiple therapeutic areas including osteoporosis, obesity, diabetes, autism, respiratory diseases and inflammatory conditions. Additional information about Nastech is available at http://www.nastech.com.
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Nastech to obtain additional funding; (ii) the ability of Nastech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) Nastech's and/or a partner's ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) Nastech's and/or a partner's ability to obtain required governmental approvals; and (v) Nastech's and/or a partner's ability to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Nastech's most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Nastech assumes no obligation to update and supplement forward-looking statements because of subsequent events.
SOURCE: Nastech Parmaceutical Company Inc.