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news.Nastech Pharmaceutical Company has reported that its partner, Merck & Co, has initiated a phase I study for PYY3-36 nasal spray for the treatment of obesity.
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The investigational PYY3-36 nasal spray is designed to deliver the natural, appetite-regulating hormone PYY directly to the bloodstream. Nastech has completed three phase I clinical trials, each designed to answer specific questions regarding tolerability, dosing and scheduling.
“This study being conducted by Merck builds upon Nastech’s PYY clinical program. To date, 63 subjects have received more than 900 doses of intranasal PYY, a synthetic form of the naturally-occurring peptide,” said Dr Gordon Brandt, executive vice president of clinical research at Nastech. “We are pleased that Merck is moving forward with its clinical work on the PYY program and we look forward to their continued progress.”
Under the terms of the previously announced agreement, Nastech and Merck will jointly develop PYY. Merck will assume primary responsibility for clinical and non-clinical studies and regulatory approval, while Nastech will be responsible for all manufacturing of PYY-related product. Merck will lead and fund commercialization, with Nastech having an option to co-promote the product in the US.
In earlier phase I clinical studies performed by Nastech, PYY3-36 was generally well tolerated, with the only side effects at one percent or greater being nausea, headache and dizziness.