June 18, 2007
Barrier reported mixed results from a phase II/III trial of liarozole for the treatment of ichthyosis. This randomized, double-blind, placebo-controlled dose ranging study enrolled 64 subjects who received placebo or liarozole (75 mg or 150 mg) daily for 12 weeks. The trial failed to reach statistical significance in the primary efficacy endpoint of "effectively treated". This was defined as the percentage of subjects who obtained at least a 2 point reduction in investigator's global assessment (IGA) score as defined on a 5 point scale. The response rates for the primary endpoint were 41% for the 75 mg dose, 50% for the 150 mg dose versus 11% for placebo (p=0.2193 and p=0.0557, respectively). The mean IGA score at week 8 and the overall scaling score at weeks 8 and 12 reached statistically significant differences in both liarozole groups compared to placebo (p < 0.05). The mean IGA score at week 8 was reduced by 36% and 43% for the 75 and 150 mg liarozole treatment groups, respectively versus 3% for placebo. Treatment was well-tolerated across both active arms, with no reports of drug-related serious adverse events. Based on the results, Barrier decided to discontinue the development of liarozole.