Barrier skin drugs show promise in phase IIa
Rambazole is a novel retinoic acid metabolism-blocking agent (RAMBA). A review of initial phase IIa trial data from ten 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 eight consecutive weeks. 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 200mg, once daily for one, three or five days demonstrated response rates at day 28 of 60% for one day of treatment and between 78% and 100% 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. "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 IIb trials," stated Dr Geert Cauwenbergh, chairman and CEO of Barrier Therapeutics. Following further analysis of these data from the European phase IIa trials, Barrier expects to submit trial data as part of investigational new drug (IND) applications to the FDA. The company plans to begin US phase IIb clinical trials with Rambazole in psoriasis by mid-year 2005, and with Azoline during the second half of the year.