Swiss-based Basilea Pharmaceutica’s investigational compound Toctino (oral alitretinoin) has met study endpoints in its US Phase III HANDEL study in patients with severe chronic hand eczema (CHE) refractory to potent topical corticosteroids.
In the randomised double-blind placebo-controlled multicentre HANDEL study, 596 adult patients were randomised either to a once-daily dose of 30mg alitretinoin or placebo for a treatment duration of up to six months.
Based on the primary outcome measure Physician Global Assessment (PGA) in the intent-to-treat population, 40% of patients treated with alitretinoin achieved clear or almost clear hands compared to 15% treated with placebo.
The secondary outcome measure of the Patient’s Global Assessment (PaGA) showed that 39% of patients treated with alitretinoin scored themselves as cleared or almost cleared, compared to 14% of patients treated with placebo.
The mean reduction in score values was found to be 54% in patients treated with alitretinoin versus 30% for patients treated with placebo, as measured by the modified Total Lesion Symptom Score (mTLSS).
Basilea Pharmaceutica International chief executive officer Anthony Man said the topline results of the large prospective randomised trial in patients in the US are consistent with previous randomised international studies.
"We plan to discuss the final study results and the requirements for a risk evaluation and mitigation strategy (REMS) with the FDA in the second half of 2012 in the context of a potential filing of a New Drug Application in the US," Man added.
Toctino is currently marketed in nine European countries as well as Canada, and is approved in a further 17 European countries and Israel as a once-daily capsule for the treatment of adults with severe CHE.
Basilea Pharmaceutica develops innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections, oncology and skin diseases, targeting the medical challenge of resistance and non-response to current treatment options.