| | Barrier Therapeutics Announces Promising Results from On-going Phase 2a Study of Pramiconazole in Onychomycosis Novel Oral Broad-Spectrum Antifungal Agent Demonstrates Interesting Efficacy
With Once Weekly Dosing PRINCETON, N.J., October 19, 2007 – Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company that develops and markets dermatology products, today announced promising results from its on-going Phase 2a proof-of-concept study with pramiconazole, its novel oral broad-spectrum antifungal product candidate, in patients with onychomycosis (nail fungus) of the toenails. Pramiconazole has previously demonstrated positive results in clinical studies in tinea pedis (athlete’s foot), tinea corporis (ring worm), tinea cruris (jock itch), tinea versicolor, vaginal candidiasis and seborrheic dermatitis. “Based on research thus far, pramiconazole may offer an important breakthrough in antifungal therapy, offering effective results with less frequent dosing than currently available drugs,” said James Del Rosso, DO, Dermatology Residency Director, Valley Hospital Medical Center, Las Vegas, Nevada and Private Practice, Las Vegas, Nevada. Dr. Del Rosso will present highlights from this clinical trial later today at the 26th Anniversary Fall Clinical Dermatology Conference® in Las Vegas, Nevada. Results from 18 patients at week 16 of the study, one month after completing once weekly treatment for 12 weeks, indicate a marked onset of clinical improvement in total signs and symptoms (p=0.001)1 of onychomycosis as measured by nail plate thickening, discoloration and overall appearance of the affected toenail. Considering the slow outgrowth of toenails, clinical improvement at this early time point is potentially a key observation. In addition, 4 of 13 patients (31%) who were evaluated at three months post-treatment demonstrated both mycological cure and a significant1 decrease in clinical signs and symptoms of the affected toenail. To date no patients have reached the final evaluation visit at week 48, nine months after the end of treatment. “These data further demonstrate pramiconazole’s broad spectrum activity against dermatophytes, yeasts and molds, and, given the encouraging mycological and clinical efficacy in nail fungus, we believe the program warrants full development in this highly prevalent infection,” commented Dr. Braham Shroot, Chief Scientific Officer of Barrier Therapeutics. “Using data from this study combined with additional pharmacokinetic studies, we will determine the dosing regimens for future dose-ranging studies. Pramiconazole could address an unmet need for a new, more convenient, and possibly safer once weekly treatment option for the 35 million people in the United States who suffer from the chronic, recurring condition.” |
