LIPONEX CHOLESTEROL DRUG FAILS IN STUDY

Liponex has announced results of the Phase I/II trial of its lead product, CRD5. CRD5 is being developed for the treatment of dyslipidemia and heart disease. Results showed, to date, that CRD5 was safe and that the drug formulation was stable throughout the trial. However, the mean increase in HDL levels from the baseline, in both the 1- and 3-gram dosages, was less than 5 percent and not statistically significant.

The patient-to-patient variation was high, and while some patients showed a strong increase in HDL, other patients had negative response. The company said it will continue to assess the data from this trial over the next several weeks.

"This trial data did not meet expectations consistent with the efficacy data seen in earlier preclinical and clinical studies. However, the trial provided us with important information to continue development, and we remain confident that this compound is still a viable drug candidate in a hugely attractive market space," Bill Dickie, president and CEO of Liponex, said.

The single-blind, Phase I/II, dose-ranging trial enrolled 56 dyslipidemic patients, including patients with both low HDL and high LDL. Following a dietary lead-in period, patients were given daily doses of CRD5 in capsule form. The primary endpoints for the trial were safety and an increase in serum HDL, with triglyceride and LDL reductions as secondary endpoints. After receiving and reviewing a letter from the principal investigator in January, the company suspended patient treatment at the highest dose level of 5 grams per day. The modification to the trial was based on the incidence of gastrointestinal adverse events that resulted in an unacceptable high level of patient withdrawal from the highest dose group.