PHENOMIX INITIATES PHASE II CLINICAL TRIAL OF PHX1149 FOR TYPE 2 DIABETES
AND PRESENTS PHX1149 DATA AT ADA
San Diego, CA, June 8, 2006 — Phenomix Corporation, a drug discovery and development company, announced today the initiation of a Phase II clinical trial of PHX1149, a novel orally administered inhibitor of DPP4 for the treatment of type 2 diabetes. Phenomix' clinical trial is a double-blind, randomized, placebo-controlled study in patients with type 2 diabetes.
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.
Phenomix will summarize the preclinical development of PHX1149 and present promising Phase I safety and DPP4 inhibition data in a scientific poster to be presented June 9-13 at the 66th Scientific Sessions of the American Diabetes Association. The poster is titled 'Preclinical Development of PHX1149, an Orally Available, Potent and Selective DPP4 (dipeptidyl peptidase) Inhibitor'.
Phenomix' Phase II trial is being conducted at multiple sites in the United States, 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.
Type 2 diabetes is reaching epidemic proportions and is a health risk for a significant percent of the industrialized world population. There is a pressing need for new safe and effective therapies.
"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 Laura K. Shawver, Ph.D., chief executive officer 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."
About Phenomix Corporation
Phenomix is a drug discovery and development company building a portfolio of novel therapeutics for the treatment of metabolic syndrome and other human diseases. Phenomix’ lead clinical candidate, PHX1149, is in Phase II testing as an orally available treatment for type IIdiabetes. Phenomix is based in San Diego, California and Canberra, Australia. For more information, visit www.phenomix.com.
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