Barrier Therapeutics Announces Azoline (Pramiconazole) Dose Ranging Study in Tinea Versicolor Meets Primary and Secondary Endpoints
Oral Formulation of Novel Antifungal Agent Shown to Be Highly Effective
PRINCETON, NJ, Mar 27, 2007 (MARKET WIRE via COMTEX News Network) — Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company that develops and markets dermatology products, today announced positive results from its completed Phase 2b dose ranging study for its novel oral antifungal product candidate pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of effectively treating tinea (pityriasis) versicolor, a common skin fungal infection characterized by a discolored, scaly, itchy rash primarily on the back, chest and upper arms. In addition, the secondary endpoints of complete cure, mycological cure and investigators’ global assessment achieved statistical significance.
“We are extremely pleased with these excellent study results, which provide a solid medical and scientific foundation for continuing to advance the development of pramiconazole for fungal infections,” commented Geert Cauwenbergh, Ph.D., Chief Executive Officer of Barrier Therapeutics. “With these data now in hand, we will begin to seek a development and commercialization partner for this important compound.”
Study Design and Results
The randomized, double-blind, placebo-controlled dose ranging study enrolled 147 patients in six treatment groups. The study results demonstrated a positive linear dose response (p < 0.001) for the primary endpoint “effectively treated” at day 28. Effectively treated was defined as significant reduction in disease signs and symptoms, including redness, scaling and itching, and complete mycological cure. Response rates for the primary endpoint ranged from 35% for the lowest dose to 85% for the highest dose as compared to 16% for placebo.
The drug was well-tolerated across all active treatment arms, and there were no reports of drug-related serious adverse events. Detailed results of this Phase 2b dose ranging trial will be presented at a scientific meeting later this year.
About Pramiconazole (previously known as Azoline)
Pramiconazole, a novel antifungal agent is being developed by Barrier Therapeutics as a potential short course treatment for acute skin and mucosal fungal infections, as well as a potential once weekly treatment for chronic fungal infections such as onychomycosis (nail fungus). In 2005, the Company conducted Phase 2a trials with pramiconazole in tinea pedis (athlete’s foot), tinea corporis (ring worm), tinea cruris (jock itch), tinea versicolor and seborrheic dermatitis. A Phase 2a clinical trial in toenail onychomycosis with once a week dosing of pramiconazole is currently ongoing.
About Barrier Therapeutics
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of products in the field of dermatology. Barrier Therapeutics currently markets three pharmaceutical products in the United States: Xolegel(TM) (ketoconazole, USP) Gel, 2%, for seborrheic dermatitis; Vusion(TM) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment, for diaper dermatitis complicated by documented candidiasis; and Solage(R) (mequinol 2.0%, tretinoin 0.01%) Topical Solution, for solar lentigines. Barrier Therapeutics has other product candidates in various stages of clinical development for the treatment of a range of dermatological conditions, including acne, psoriasis, onychomycosis and other fungal infections such as tinea versicolor. The company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada. More information about Barrier Therapeutics can be found on its corporate website at: www.barriertherapeutics.com.
Xolegel, Vusion and Solage are trademarks of Barrier Therapeutics, Inc.
Safe Harbor Statement
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the “Safe Harbor” provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s business development and clinical development plans for pramiconazole. Forward-looking statements provide Barrier’s current expectations or forecasts of future events. Barrier’s performance and financial results could differ materially from those reflected in these forward-looking statements due to the marketplace acceptance of Barrier’s products, Barrier’s ability to execute its commercial and clinical strategy, the decisions of regulatory authorities, the results of clinical trials and strategic decisions regarding its pipeline, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in the company’s Annual Report on Form 10-K for the year ended December 31, 2006 which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.
In addition, please note that success in clinical trials does not mean that subsequent trials will confirm earlier findings. No assessment of the efficacy or safety of any product candidate can be considered definitive until all clinical trials needed to support a submission for marketing approval are complete.
SOURCE: Barrier Therapeutics, Inc.