Basilea Pharmaceutica: Alitretinoin Could Be Safer Alternative

Independent Swiss pharmaceutical company Basilea has announced that its dermatology drug alitretinoin has shown positive results in a second phase III clinical trial for the treatment of severe chronic hand dermatitis. Based on these results, alitretinoin could fill an important unmet need for a safer therapy in this indication.

Chronic hand dermatitis is a relapsing inflammatory skin disease, which predominantly affects adults. In many instances the dermatitis can be so severe and disabling that it causes psychological distress. Treatment options include topical corticosteroids and topical immunomodulators, such as Novartis’ Elidel (pimecrolimus) and Astellas’ Protopic (tacrolimus); drugs which are approved for atopic dermatitis but not specifically for chronic hand dermatitis.

These treatment options include both topical and, in severe cases, oral therapies. Corticosteroids and immunomodulators are used to treat this condition but side effects can limit their long-term use. Moreover, some patients become refractory to treatment. There is an unmet medical need for safer oral treatments for the severe dermatitis population.

The phase III trial investigated the safety and efficacy of a re-treatment course of alitretinoin in patients who had previously achieved clear or almost clear hands after initial treatment with the drug. Patients with recurrent disease after earlier therapy received 30mg alitretinoin, 10mg alitretinoin or placebo once-daily over a course of 12 to 24 weeks. About 80%, 48% and 10% of patients, respectively, achieved clear or almost clear hands. Patients who had no or partial response to previous treatment were given 30mg alitretinoin and 47% of patients achieved clear or almost clear hands. The trial results have confirmed the potential for this drug in the treatment of hand dermatitis.

Safer oral drugs for the severe patient population represents a significant unmet need in atopic dermatitis. Basilea’s alitretinoin has demonstrated a good efficacy and safety profile in recent clinical trials, and based on these data, alitretinoin will meet the need for safer oral therapies. The drug will further address another unmet need for improved treatment compliance because of its once-daily dosing.