PPD and Syrrx file to advance diabetes drug into phase I

PPD and Syrrx entered a collaboration agreement in November 2003 to jointly develop and commercialize Syrrx-designed dipeptidyl peptidase IV (DPP IV) inhibitors for the treatment of diabetes and other human diseases.

An investigational new drug (IND) application for DPP IV inhibitor SYR322 was submitted last September – less than 30 months from first experiments on the target. The companies have already advanced SYR322 into multi-dose studies in patients and expect to initiate phase II studies in first quarter 2005.

Studies to date indicate that DPP IV plays an important role in regulating insulin levels in the body. In early-stage clinical trials conducted primarily by large pharmaceutical companies, orally-delivered DPP IV inhibitors reduced blood glucose and increased insulin response in patients.

These data indicate that small molecule inhibitors that target DPP IV could be potential treatments for human diseases including type 2 diabetes, obesity, high cholesterol and other forms of metabolic syndrome.

“Based on pre-clinical data, this second DPP IV inhibitor is as attractive as our DPP IV inhibitor currently in phase I studies,” said Stephen Kaldor, Syrrx president and chief scientific officer.

“The primary differentiator between the two is that each is from a different and separately patentable chemical class. We believe DPP IV is a promising, clinically validated target and that both SYR322 and SYR619 have the potential to be a best-in-class drug in the large and growing diabetes market.”

Under the terms of the agreements announced in November 2003, PPD made an equity investment in Syrrx, is providing pre-clinical and clinical development resources and expertise for the collaboration, and will fund the majority of pre-clinical and clinical studies through phase IIb development of selected DPP IV inhibitors.