PHENOMIX RELEASES FINDINGS ON DPP4 INHIBITOR FOR DIABETES

Phenomix has announced the completion of a multinational Phase IIa clinical trial of PHX1149, a novel orally administered inhibitor of DPP4 for the treatment of Type 2 diabetes mellitus. Statistical analysis of the trial data shows significant improvement of postprandial blood glucose levels and HbA1c with once-daily dosing. There was no apparent pattern of drug-related adverse events, and PHX1149 demonstrated a tolerability profile comparable to placebo at all dose levels tested. The favorable tolerability data are consistent with the high selectivity of this compound, the low peak-to-trough pharmacokinetic characteristics and low cellular permeability, according to the company.

"Our clinical results show that PHX1149 meets or exceeds the high bar for efficacy and tolerability set by other DPP4 inhibitors. We believe that our next clinical study will further demonstrate PHX1149's potential to provide patients significantly increased benefits over existing therapies," Laura Shawver, president and CEO of Phenomix, said.

DPP4 is a serine protease that has emerged as an important target for the treatment of Type 2 diabetes, the company said. Inhibiting DPP4 increases the physiological levels of regulatory peptides, such as GLP-1, an important modulator of insulin response and digestion.

The study, a double-blind, placebo-controlled, parallel-group trial with three active doses, was conducted at multiple sites in the U.S., Mexico and Australia. PHX1149 or placebo was administered orally to 174 Type 2 diabetic patients over a four-week period. PHX1149 met its primary endpoint of improved postprandial as well as secondary endpoint measurements related to HbA1c and GLP-1 levels, the principal mediator of the biological effects of DPP4 inhibition.

Phenomix expects to commence a 12-week Phase IIb study in the first half of 2007 and Phase III trials in 2008.