>>PRINCETON, N.J., Jan. 12 /PRNewswire-FirstCall/ -- Barrier Therapeutics, Inc. (Nasdaq: BTRX - News), a pharmaceutical company developing products in the field of dermatology, today reported positive Phase 2a data for both oral Rambazole(TM) in the treatment of psoriasis, and for oral Azoline in the treatment of superficial fungal infections.
Rambazole is a novel retinoic acid metabolism-blocking agent (RAMBA). A review of initial Phase 2a trial data from 10 patients with moderate to severe psoriasis demonstrated a reduction in the PASI score (a symptom severity score in psoriatic patients) by an average of 50% in patients treated with 1mg once daily for 8 consecutive weeks. These PASI scores were measured at week 10, two weeks after stopping treatment. There were no serious treatment-related adverse effects reported, while non-serious side effects experienced by this limited patient group included some dryness of skin and lips. This study is ongoing and is expected to include a total of 17 patients upon completion.
Azoline is a new, orally active antifungal agent. Phase 2a trial data from 67 patients with various fungal infections of the skin treated with 200mg, once daily for 1, 3 or 5 days demonstrated response rates at day 28 (more than three weeks after treatment) of 60% for 1 day of treatment and between 78% and 100% for 3 to 5 days of treatment, depending on the type of skin condition. The drug was studied in tinea pedis (athlete's foot), tinea corporis/cruris, tinea versicolor and seborrheic dermatitis. There were no serious treatment-related adverse effects reported.
"These initial clinical data for the oral dose forms of both Rambazole and Azoline clearly support the continued advancement of these drug candidates into Phase 2b trials," stated Geert Cauwenbergh, Ph.D., Chairman and Chief Executive Officer of Barrier Therapeutics, Inc. "Upon completing a more comprehensive analysis of these data, Barrier expects to submit data from these European Phase 2a trials as part of IND applications to the FDA. Our goal is to initiate Phase 2b clinical trials in the United States with Rambazole in psoriasis by mid-year, and with Azoline during the second half of 2005."
Dr. Cauwenbergh is scheduled to present this data as part of an update to the investment community on Barrier's clinical-stage product pipeline today at 10:00 am, Pacific Time/ 1:00 pm, Eastern Time at the 23rd Annual JPMorgan Healthcare Conference in San Francisco, CA. Dr. Cauwenbergh's presentation will be available live via a webcast and will be archived and accessible through the Company's website at barriertherapeutics.com. The presentation will be archived and available for up to 90 days.
About Rambazole
Rambazole is Barrier's second product candidate based on the Retinoic Acid Metabolism Blocking Agent (RAMBA) class of molecules. Studies to date suggest that Rambazole is more selective and more active than first generation RAMBA- based product candidates. The Company is developing an oral formulation of Rambazole for the treatment of psoriasis and severe acne, as well as a topical formulation for psoriasis, acne, and wrinkles. One European Phase 2a study in psoriasis and one in acne are ongoing for the oral dose form of the drug. Barrier anticipates submitting an IND to the FDA and moving forward with Phase 2b trials in the United States during the first half of 2005.
About Azoline
Azoline is a broad-spectrum antifungal agent that Barrier is developing as a short course oral treatment for skin and mucosal fungal infections. Studies have shown that Azoline has a half-life in the body of nearly three times longer than that of itraconazole, which may enable a more convenient dosing regimen. Barrier has completed four European Phase 2a clinical trials for Azoline and anticipates submitting an IND to the FDA and moving forward with Phase 2b trials in the United States during the course of 2005.<<
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