Moberg Derma Starts Recruiting Patients for Clinical Phase III Trial for its K301 Product Candidate to Treat Seborrheic Dermatitis

The Swedish pharmaceutical company Moberg Derma, which focuses on skin diseases, has started recruiting patients for a clinical phase III trial of the K301 product candidate to treat seborrheic dermatitis of the scalp. The company plans to include 180 patients in the study at around 20 clinics in Sweden. The results from the trial are expected in the second half of 2008.

”We recently received the approval from the Swedish Medical Products Agency (MPA) and Ethical Committee and will now initiate our second phase III study” says the company’s CEO, Peter Wolpert. ”If the promising data from our previous phase II trial can be reproduced in this larger study, we will be able to offer patients a novel and efficacious topical treatment for seborrheic dermatitis of the scalp.”

K301 is a novel non-steroid topical treatment against seborrheic dermatitis of the scalp and is in the ongoing study applied once daily during a four-week treatment period.

An estimated 5 percent of the population has recurring seborrheic dermatitis of the scalp and skin. It is a chronic condition where the fungus malassezia furfur is believed to play an important role. There is currently no cure against seborrheic dermatitis. Available treatments therefore aim at minimizing the symptoms, particularly erythema, desquamation and itching. The most common treatments are anti-inflammatory drugs (e.g. corticosteroids) or anti-fungal preparations (e.g. ketokonazol). The global eczema market is expected to grow by 3 percent per year and reach more than 1 billion USD by 2010.

Moberg Derma is developing several dermatological products based on the patented Kaprolac® principle. A phase III trial involving the K101 product candidate for the treatment of nail fungus (onychomycosis) is ongoing in Sweden and Poland. Results from the study are expected in the second half of 2008.