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OSI Reports Positive Diabetes Treatment Study Results

Posted on: Friday, 7 September 2007, 15:00 CDT

OSI Pharmaceuticals has reported that Prosidion, its UK subsidiary focused on the discovery and development of diabetes and obesity therapeutics, has reported positive results from a metformin drug interaction study in healthy volunteers with its dipeptidyl peptidase-IV inhibitor.

The company reported that exposure to its drug and metformin did not change to a clinically relevant extent when they were co-administered, compared with each therapy alone.

"This positive result supports future clinical studies of PSN9301 in combination with metformin, which is what we believe to be the ideal clinical positioning for DP-IV inhibitors," stated Anker Lundemose, president of (OSI) Prosidion.

"Furthermore, the short systemic duration of action of PSN9301, its principal differentiation from other DP-IV inhibitors, was not changed by combination with metformin," he added.

The study was a randomized, open-label, three-period cross-over design trial in 24 healthy volunteers. In the study, PSN9301 was dosed at 300mg and metformin at 850mg, each given as a single dose on day 1, followed by three times daily dosing on day 2.

In one treatment period, the compounds were dosed together at meal times and in the other two periods, each compound was dosed alone. Extensive pharmacokinetic analysis showed no clinically significant changes in exposure to either PSN9301 or metformin when given in combination.

Prosidion said that as expected, reduction in post-meal glucose concentrations was greater with the combination than with either therapy alone, and the combination was well tolerated within this study.

A final commercial formulation of PSN9301 is being developed to support long-term, double-blind, placebo-controlled studies, and PSN9301 is scheduled to enter a Phase IIb study in early 2008.

Source: Datamonitor

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