CRx-401

A novel insulin sensitizer designed to provide anti-diabetic activity without promoting weight gain.

• Description: Combination of bezafibrate, an anti-cholesterol agent, and a low dose of diflunisal, an analgesic.
• Data: Demonstrated preclinical efficacy in decreasing fasting blood glucose and insulin resistance without promoting weight gain.
• Formulation: Once-daily co-formulated tablet in development.
• Commercial Opportunity: Novel anti-diabetic agent for poorly controlled diabetes patients with elevated triglycerides and low HDL.

There are 20 million patients in the U.S. with diabetes.

Status: Phase 2a clinical data in Type 2 diabetes expected in 2008.

CRx-401 consists of a low dose of the analgesic diflunisal in conjunction with a modified-release therapeutic dose of bezafibrate, an anti-cholesterol agent. In third-party clinical studies, the dose of bezafibrate contained in CRx-401 has been observed to have a positive impact on cellular pathways that influence glycemic and lipid profiles, and this dose has proven to be well tolerated in clinical trials. Unlike other NSAIDs, or non-steroidal anti-inflammatory drugs, the dose of diflunisal in CRx-401 has demonstrated in preclinical studies the ability to synergistically enhance the anti-diabetic effects of bezafibrate through novel disease-targeted mechanisms.