BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

Turku- Finland 2009-07-03

BioCis Pharma Ltd., a privately-held drug development company with its headquarters in Turku, Finland, announced positive results from its Phase IIa clinical trial of ProtoCure(TM) emulsion cream, the company's novel topical drug for dermatology. This double-blind, placebo-controlled study, conducted in Finland, included 13 patients with mild to moderate atopic dermatitis who applied the ProtoCure emulsion cream to the affected skin areas twice daily for up to four weeks. The objectives were to evaluate the tolerability, pharmacokinetics, and efficacy of the topical treatment.

Study results showed excellent safety profile, and no serious adverse events were reported during the study. No patient dropped out due to adverse side effects of the treatment. Pharmacokinetic analyses showed no systemic exposure to the active ingredient of the product. Efficacy was assessed by performing instrumental measurements of skin lesion redness (erythema) and skin barrier function by trans-epidermal water loss (TEWL) during the 28-day period. Physician assessments, such as Eczema Area and Severity Index (EASI) were also evaluated. ProtoCure emulsion cream was superior to placebo in decreasing skin redness and improving skin barrier function. Statistically significant improvement was observed as early as day 10 after begining treatment. There was also a significant improvement in EASI score over the whole treatment period for ProtoCure emulsion cream as a sign of positive treatment effect. The EASI score difference did not reach statistical significance when compared to placebo, mainly due to the small number of patients studied.

"We are very pleased with the promising results of this study," says Lasse Leino, CEO of BioCis Pharma. "Skin barrier dysfunction is now recognized as a hallmark feature of atopic dermatitis. Any drug showing capacity for restoring this disturbance has significant potential in atopic dermatitis therapy. Based on our results, ProtoCure(TM) emulsion cream holds great promises in the treatment of inflammatory skin disorders."

Atopic dermatitis is a chronic inflammatory disease of the skin with an onset typically already in infancy. It affects up to 20 per cent of the general population in the Western countries, and the prevalence rate is rising. Atopic dermatitis may significantly impair the quality of life of those affected. Existing treatments often have undesirable side effects and do not always meet the needs of patients.

BioCis Pharma Ltd. is a Karolinska Development portfolio company.