Basilea Pharmaceutica Ltd. has 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).

This randomised double-blind phase III pivotal study is the largest therapeutic trial ever performed in chronic hand dermatitis. In the study, 1032 patients whose severe chronic disease was unresponsive to potent topical steroids were randomised 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 clears 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 per cent of patients and 28 per cent in the 10mg group reached the primary endpoint. The response in the placebo group was 17 per cent.

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.

"Patients with severe chronic hand dermatitis often fail on topical treatments. Alitretinoin has the potential to become a new treatment standard for those who currently face social and professional disability and handicap due to intractable disease," commented Professor Thomas Ruzicka of the Ludwig-Maximillian University Munich, Germany, one of the world's largest dermatology clinics.

Dr Anthony Man, Basilea's CEO observed, "These are compelling data. Patients' responses to treatment with alitretinoin were remarkable, particularly for this population whose disease is long-term and unresponsive to other treatments. For the first time, patients who currently have no effective treatment available may have a viable option." Dr Man continued, "These results highlight the benefits to patients which Basilea's focus on high unmet medical needs can bring. This is the second of Basilea's compounds, which has successfully completed phase III this year. Subject to the appropriate regulatory approvals, alitretinoin may become an important driver of Basilea's future growth. Basilea is now building a marketing and sales capability focused on the hospital and specialty sectors to bring these new medicines to patients and to treating physicians."

Hand dermatitis is a common skin disease and is often chronic and relapsing. It is estimated to affect up to 10 per cent of the general population. The more severe, chronic form of the condition is thought to affect up to 7 per cent of these patients, many of whom do not respond, or no longer respond to topical corticosteroids.

Basilea estimates there are at least one million patients in Europe and North America with refractory severe CHaD for which currently no approved, effective pharmaceutical treatment is available.

For the patient, severe CHaD can be a frustrating and debilitating disease. Patients often suffer for years from erythema, blisters, vesicles, scaling and fissures, which can cause chronic pain and functional impairment of the hands. Studies suggest these patients have a significantly reduced quality of life and the majority experience social or emotional distress and sleep disorders. It is reported that up to 20 per cent of sufferers have to leave their jobs and one patient in five takes prolonged sick leave resulting in high socio-economic and individual patient burden.

Alitretinoin is an investigational drug being developed by Basilea as a novel treatment for severe refractory Chronic Hand Dermatitis (CHaD), a complex disease for which no effective treatment options are currently available.

Basilea Pharmaceutical Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland. Basilea's fully integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs.