Barrier Therapeutics Says Liarozole Phase 2/3 Study Misses Goal, Shares Fall
PRINCETON, NJ -- Jun 14, 2007 -- Barrier Therapeutics, Inc., a pharmaceutical company that develops and markets dermatology products, today announced results from its completed Phase 2/3 study of liarozole in lamellar ichthyosis, a rare genetic disorder (incidence of approximately 1 in 200,000) which is characterized by a thick scaling of the skin over large body areas. Study results showed liarozole, dosed at 75 mg and 150 mg per day for 12 weeks, was well-tolerated and "effectively treated" the disorder in 41% and 50% of the patients, respectively. The primary efficacy endpoint, "effectively treated," was defined as the percentage of patients that obtained at least a 2 point reduction in investigator's global assessment (IGA) score as defined on a 5 point scale.
The randomized, double-blind, placebo-controlled dose ranging study enrolled 64 patients in three treatment groups. Patients received placebo, 75 mg or 150 mg of liarozole daily for 12 weeks, randomized 1:3:3, respectively. Response rates for the primary endpoint were 41% (11 of 27 patients) for the 75 mg dose, 50% (14 of 28 patients) for the 150 mg dose and 11% (1 of 9 patients) for placebo. The p-values for the 75 and 150 mg per day groups compared to placebo were p=0.2193 and p=0.0557, respectively.
For the secondary endpoints of mean IGA score at week 8 and the overall scaling score at weeks 8 and 12, both liarozole groups achieved statistically significant differences from placebo (p