LIPONEX BEGINS DOSING IN DYSLIPIDEMIA TRIAL
Liponex has initiated patient dosing in its Phase I/II trial of its lead compound CRD5, being developed for the treatment of dyslipidemia and heart disease. The company also said it has completed recruitment for the study.
The single-blinded, dose-ranging trial has enrolled in 50 dyslipidemic patients (patients with low HDL and high LDL). Following a dietary lead-in period, patients are being given daily doses of CRD5 in capsule form. Each patient will receive a placebo dose plus three different doses of CRD5, with the total treatment time following dietary lead-in totaling 12 weeks. The primary endpoints for the trial are safety and an increase in serum HDL, with triglyceride and LDL reductions as secondary endpoints. Patient treatment is expected to last through 2006 with the company expecting to report results in the first quarter of 2007.
Liponex previously completed three Phase I trials, including one single-dose trial and two multi-dose trials of two-week duration, both with and without placebo. These trials demonstrated that an unformulated version of CRD5 was safe and well-tolerated with no significant adverse events. Efficacy data, although based on a small population in the Phase I trials, showed that CRD5 raised HDL levels by approximately 20 percent and lowered blood triglycerides by approximately 40 percent in healthy subjects over the two-week period.
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