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www.fdanews.com/articles/67556-barrier-reports-positive-phase-iia-data-for-rambazole-and-azoline

BARRIER REPORTS POSITIVE PHASE IIA DATA FOR RAMBAZOLE AND AZOLINE

January 14, 2005

Barrier Therapeutics has reported positive Phase IIa data for both oral Rambazole 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. A review of initial Phase IIa 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 percent in patients treated with 1 mg once daily for eight 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 IIa trial data from 67 patients with various fungal infections of the skin treated with 200 mg, once daily for one, three or five days demonstrated response rates at Day 28 (more than three weeks after treatment) of 60 percent for one day of treatment and between 78 percent and 100 percent for three to five 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.