Basilea Reports Positive Phase III Results for Alitretinoin
Basilea Pharmaceutica Ltd. announced that its placebo-controlled pivotal phase III BACH trial (Benefit of Alitretinoin in Chronic Hand dermatitis) successfully met its primary objective. Alitretinoin was effective in patients suffering from severe and refractory chronic hand dermatitis, as determined by the stringent endpoint of clear and almost clear hands. Currently, no approved treatment exists for this debilitating disease which prevents patients from using their hands normally. These positive data will form the basis of regulatory submissions later this year.
The positive outcome of this study may allow alitretinoin to become the first product available to treat an estimated one million patients who suffer from severe refractory Chronic Hand Dermatitis (CHaD).
In the double-blind phase III pivotal study, 1032 patients whose severe chronic disease was unresponsive to potent topical steroids were randomized either to a once-daily dose of 30mg or 10mg of alitretinoin, or placebo for a treatment duration of up to 24 weeks. The primary endpoint of the study was the proportion of patients whose hands were rated as clear or almost clear by the Physicians Global Assessment.
Alitretinoin's efficacy was significantly superior to placebo in both the high and the low dose regimen. The difference between the active groups and placebo were highly statistically significant. In the 30mg group 48% of patients (p<0.001) and 28% in the 10mg group (p=0.004) reached the primary endpoint. The response in the placebo group was 17%.
Alitretinoin was generally well tolerated with a safety profile consistent with that reported in the phase II clinical study. The most frequent adverse events were headache and blood lipid elevations. These were dose-dependent and reversible.
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