Liponex' CRD5 misses Ph I/II efficacy endpoint

Liponex, a Canadian biopharmaceutical firm, reported disappointing results from a Phase I/II clinical trial of its lead product, CRD5, a treatment for dyslipidemia and heart disease. While CRD5 was safe and the drug formulation was stable, the mean increase in high-density lipoprotein levels from the baseline, in both the 1g and 3g dose groups, was under 5% and not statistically significant.

Liponex chief executive Bill Dickie said that, while this trial data did not meet expectations consistent with the efficacy seen in earlier preclinical and clinical studies, he "remains confident that this compound is still a viable drug candidate in a hugely attractive market space." The firm will continue its formulation development work, culminating in a second Phase I/II trial with results anticipated in early-2008. The goal of this study will be to finalize a formulation and dose level for a US Food and Drug Administration submission, he noted.