Barrier Therapeutics, Inc., a pharmaceutical company developing products in the field of dermatology, reported positive phase 2a 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 (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 per cent 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, the company release says.
Azoline is a new, orally active antifungal agent. 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, chairman and CEO 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," Cauwenbergh added.