Barrier Therapeutics Announces Positive Phase 2a Data for Oral Hivenyl(TM) in the Treatment of Itch in Atopic Dermatitis
- Category: Small Molecules
- Published on Thursday, 18 January 2007 02:00
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PRINCETON, NJ, USA | Jan 17, 2007 | Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, today announced results of a Phase 2a proof-of-concept study of oral Hivenyl(TM) in the treatment of moderate to severe itching related to atopic dermatitis which indicate that Hivenyl significantly reduces itch symptoms without signs of sedation. Hivenyl is an oral formulation of vapitadine dihydrochloride, a novel antihistamine that Barrier Therapeutics is developing as a treatment for allergic reactions of the skin, such as those associated with hives and for the itch associated with atopic dermatitis.
"We are very encouraged by the results of this study," said Geert Cauwenbergh, Ph.D., Chief Executive Officer and Founder of Barrier Therapeutics. "It is widely believed that the anti-pruritic effects of oral antihistamines in atopic dermatitis are related to their unwanted sedating properties. This study clearly shows that this antihistamine can be effective in reducing or eliminating the annoying symptoms of itch without sedating effects."
In this multi-center, double-blind, placebo-controlled study, 44 adult patients with atopic dermatitis underwent a one-week lead-in period followed by randomization to treatment with oral Hivenyl 60 mg twice daily (n=23) or placebo (n=21) for one week. All patients were also treated daily with a topical corticosteroid and an emollient throughout the study. Nine of the 23 patients in the Hivenyl group reported either a marked improvement or an almost complete to complete relief of their itch symptoms versus none of the 21 patients in the placebo group (p < 0.01). In addition, the overall clinical severity score (Eczema Area and Severity Index, or EASI) of the atopic dermatitis lesions was reduced in those same nine Hivenyl-treated patients. The drug was well tolerated and no patients reported signs of sedation, which supports similar findings in prior studies with Hivenyl. The study was conducted in Belgium and the Czech Republic.
James J. Leyden, M.D., Professor of Dermatology at the University of Pennsylvania, commented, "These study results are quite remarkable. The apparent absence of sedation with Hivenyl could open up new avenues for the treatment of a large group of patients with troublesome itch while not affecting their alertness." Dr. Leyden serves on advisory boards for several pharmaceutical companies, including Barrier Therapeutics.
Hivenyl is an oral formulation of vapitadine dihydrochloride, an antihistamine that Barrier Therapeutics is developing as a treatment for allergic reactions of the skin, such as those associated with hives and for the itch associated with atopic dermatitis. The results of two dose escalation Phase 1 clinical trials suggest that Hivenyl inhibits allergic reactions, has a fast onset of action and does not cause sedation. In these trials, no cardiovascular side effects or sedation were experienced at doses of five to 15 times those that elicited an antihistamine response.
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 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, Solage and Hivenyl 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 potential development and therapeutic properties of Barrier's Hivenyl product candidate. 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, including those for Hivenyl, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
Barrier Therapeutics, Inc.
Anne M. VanLent
EVP & CFO
SOURCE: Barrier Therapeutics, Inc.