OSI Pharmaceuticals starts Phase IIa trial for diabetes drug
OSI Pharmaceuticals in the US has initiated a Phase IIa clinical trial for its glycogen phosphorylase inhibitor, PSN357, developed for type-2 diabetes.
OSI Pharmaceuticals in the US has initiated a Phase IIa clinical trial for its glycogen phosphorylase inhibitor, PSN357, developed for type-2 diabetes.
In the Phase IIa study, PSN357 will be administered to up to 30 type-2 diabetic patients as daily doses over an initial period of 14 days providing safety, pharmacokinetic and pharmacodynamic endpoints in a placebo controlled dose escalation design. The study is expected to last about six months.
Pre-clinical data has shown that PSN357 inhibits glycogen phosphorylase and reduces blood glucose levels in animal models with diabetes following acute and chronic dosing.
'PSN357 is the first clinical candidate to emerge from the company's internal discovery research efforts in diabetes and is designed to prevent glucose levels rising in diabetic patients by preventing glycogen breakdown to glucose in the liver,' said Anker Lundemose, president of (OSI) Prosidion, the company's UK-based diabetes research & development arm. '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,' he added.