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news.OSI Pharmaceuticals has initiated a phase IIa clinical trial for its glycogen phosphorylase inhibitor, PSN357, which the company is developing for type 2 diabetes.
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In the study, PSN357 will be administered to up to 30 type 2 diabetic patients as daily doses over an initial period of 14 days. The study will provide safety, pharmacokinetic and pharmacodynamic endpoints in a placebo controlled dose escalation design. The study is expected to last approximately six months.
PSN357, the first clinical candidate to emerge from the company’s internal discovery research efforts, is designed to prevent glucose levels rising in diabetic patients by preventing glycogen breakdown to glucose in the liver.
“We believe that PSN357, together with our DPIV inhibitor, PSN9301, which is scheduled to begin phase IIb studies this year and PSN010, our glucokinase activator, which entered phase I trials last week, together comprise an innovative clinical pipeline of novel, molecularly targeted therapies for the treatment of type 2 diabetes,” stated Dr Anker Lundemose, president of Prosidion, OSI’s UK-based diabetes R&D arm.
The initiation of the phase IIa trial follows the completion of a phase I safety and tolerability study which showed no unexpected safety or pharmacokinetic outcomes.