PHX1149 is a potent and selective inhibitor of DPP4, a serine protease that has emerged as an important target for the treatment of type 2 diabetes. Inhibiting DPP4 increases the physiological levels of regulatory peptides, such as GLP-1, an important modulator of insulin response and digestion.
The phase II trial is being conducted at multiple sites in the US, Mexico and Australia. Eligible type 2 diabetics who are currently receiving anti-diabetes medication will receive PHX1149 at different doses, or placebo, administered orally over four weeks with a primary endpoint measurement of post-meal glucose levels.
Secondary endpoints will measure post-meal insulin levels, fasting blood glucose, and levels of a number of regulatory peptides, including GLP-1. The trial will enroll approximately 150 eligible patients.
“DPP4 is an attractive target, and inhibitors have the potential to enhance the therapeutic product landscape for type 2 diabetes by providing patients a convenient and tolerable means of managing their glucose levels,” said Dr Laura Shawver, CEO and president of Phenomix. “Our preclinical and phase I results suggest that oral, once daily PHX1149 therapy is safe and well-tolerated in the clinic and has the potential to deliver significant clinical benefit to type 2 diabetic patients.”