Shares in Swiss biotechnology company Basilea have been boosted by data from a late-stage trial which shows that its new dermatitis drug has met its primary objective.
In a Phase III trial, called BACH, alitretinoin was seen to be effective in patients suffering from severe and refractory chronic hand dermatitis, “as determined by the stringent endpoint of clear and almost clear hands.”
In the study, the largest of its kind, 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. Alitretinoin's efficacy was significantly superior to placebo in both the high and the low-dose regimen.
In the group taking 30mg, 48% of patients were rated as clear or almost clear, while 28% of those taking 10mg reached the same stage. The response in the placebo group was 17%. Alitretinoin was generally well tolerated, while its most frequent adverse events were headache and blood lipid elevations.
Basilea noted that “no approved treatment exists for this debilitating disease which prevents patients from using their hands normally” and the positive data will form the basis of regulatory submissions later this year. Chief executive Anthony Man said that the study was "compelling” and “for the first time, patients who currently have no effective treatment available may have a viable option." He added that alitretinoin is the second of Basilea's compounds which has successfully completed Phase III this year, following positive data from a study of its antibiotic ceftobiprole.
Dr Man concluded by saying that subject to the appropriate regulatory approvals, “alitretinoin may become an important driver of Basilea's future growth” and the company is now building up a sales force which will be focused on the hospital and specialty sectors.