BioWorld International Correspondent

Basilea Pharmaceutica AG is moving its lead compound, BAL4079 (alitretinoin), into Phase III studies in more than 2,000 patients with severe chronic hand dermatitis who are refractory to topical therapy.

The Basel, Switzerland-based company aims to complete the study in 2006 and, if successful, could launch the product by 2007.

Two randomized, double-blind studies will compare 10-mg and 30-mg daily doses of the compound, an orally available vitamin A derivative, to placebo. The treatment period will range from 12 weeks up to a maximum of 24 weeks. The primary efficacy endpoint will be response rate, determined as the number of patients with clear or almost-clear hands according to the physicians' global assessment.

"We believe efficacy/safety data similar to the data reported for the Phase II study will be sufficient for registration," said company spokesman Sean Wells. In that study, which involved 319 patients, BAL4079 demonstrated a 53 percent response rate at 40 mg vs. a 27 percent response rate for placebo. Two lower doses, 10 mg and 20 mg, achieved response rates of 37 percent and 41 percent, respectively.

"In the Phase II we saw more headaches at 40 mg, so we selected 30 mg as the highest dose [for the Phase III]. Efficacy of the drug starts to plateau somewhere between 20 and 40 mg in that trial. Therefore, we believe that the 30-mg dose may provide the more optimal efficacy/safety profile," Wells said.