Phenomix Completes Phase 2a Clinical Trial - Diabetes Drug is Efficacious and Well ToleratedSAN DIEGO--(BUSINESS WIRE)--Mar 5, 2007 - Phenomix Corporation, a drug discovery and development company, announced today the completion of a multinational phase 2a 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.
"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," said Laura K. Shawver, Ph.D., chief executive officer and president of Phenomix.
DPP4 is 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.
"In clinical studies PHX1149 has demonstrated a predictable pharmacokinetic/pharmacodynamic profile resulting in potent and durable inhibition of DPP4 and its subsequent effects on glycemic parameters," said Julie M. Cherrington, Ph.D., executive vice president of research and development of Phenomix.
Phenomix' phase 2a trial, a double blind, placebo-controlled, parallel group study with three active doses, was conducted at multiple sites in the United States, 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 glucose (area under the curve) 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 2b study in the first half of 2007 and initiate phase 3 trials in 2008.
PHX1149 grew out of Phenomix' internal discovery and development efforts, advancing from initiation of the program to clinical trials in less than 2 1/2 years. Phenomix' hepatitis C protease inhibitor program, currently in preclinical development, is on track to repeat a rapid entry into the clinic.
About Phenomix Corporation
Phenomix is a drug discovery and development company building a portfolio of novel therapeutics for the treatment of major human diseases. Phenomix' lead clinical candidate, PHX1149, is a DPP4 inhibitor in phase 2 testing as a once daily oral treatment for type 2 diabetes. Phenomix' second program is directed at the treatment of hepatitis C through inhibition of the NS3/4A viral protease. Phenomix is based in San Diego, California. For more information, visit http://phenomix.com.
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Posted: March 2007