OSI's Prosidion says phase 2b results promising for PSN9301 to treat type 2 diabetes

By E. Janene Geiss

Philadelphia, Dec. 8 - OSI Pharmaceuticals, Inc. said Thursday that its U.K. subsidiary Prosidion reported positive preliminary results from a phase 2a proof-of-concept and dose-range-finding study with its dipeptidyl peptidase-IV (DPIV) inhibitor, PSN9301, for type 2 diabetes.

Following 14 days of therapy, PSN9301 substantially reduced glucose levels after an oral glucose tolerance test (OGTT) and was generally well tolerated with no episodes of hypoglycemia, according to a company news release.

PSN9301 is scheduled to enter into phase 2b clinical trials in mid-2006, officials said.

The phase 2a monotherapy study of PSN9301 was a randomized, double-blind, placebo-controlled, two-week in-clinic dosing and monitoring trial.

The study explored four different dose levels and two different dosing regimens of PSN9301. Fifty one patients with type 2 diabetes that had been previously treated with diet or oral anti-diabetic agents were enrolled in two separate centers.

Data from the study showed that the glucose area under the curve (AUC 0-2h) following an OGTT was significantly reduced by a range of 24% to 42% compared to placebo in the three highest dose groups after 13 days of treatment, officials said. Mean 24-hour blood glucose also was reduced by up to 13% in the highest dose groups compared to pretreatment, but this did not reach statistical significance due to the relatively small numbers of patients in the study and the short duration of dosing, officials said.

PSN9301 was generally well-tolerated with no episodes of hypoglycemia, officials said.

"We believe that PSN9301 provides us with a differentiated and competitive agent in the DPIV inhibitor arena," Anker Lundemose, president of Prosidion, said in the release.

"PSN9301 demonstrated a significant improvement in glucose levels following OGTT, met a primary strategic goal of lowering glucose concentrations after meals and did not cause hypoglycemia during 14 days of dosing. Its meal-related dosing makes it a potentially ideal candidate for combination with metformin, an anti-diabetes drug, which primarily affects basal levels of blood glucose. In addition, an increased post-prandial glucose level is an independent risk factor for macrovascular disease in type 2 diabetic patients and PSN9301 is well positioned to address this," Lundemose added.

Based in Oxford, England, Prosidion is the diabetes and obesity business team within OSI Pharmaceuticals dedicated to the discovery and development of novel drugs for the treatment of type 2 diabetes and obesity.

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