Moberg Derma Reports Positive Phase II Results for Its K301 Product Candidate for the Treatment of Seborrheic Dermatitis
The Swedish pharmaceutical company Moberg Derma, which focuses on skin diseases, is today reporting positive data from its clinical phase II trial involving the K301 product candidate. K301, which is based on the patented Kaprolac® principle, is a new non-steroid topical treatment for seborrheic dermatitis of the scalp. In the trial, two different formulations of K301 were tested against placebo. 76 percent of patients who received the selected K301 formulation responded positively to the treatment. Moberg Derma plans to conduct a phase III clinical trial for K301 with the goal to reach the market in 2009.
“We are very pleased to able to present positive results from the company’s first clinical trial,” says Peter Wolpert, CEO of Moberg Derma. ”We recently initiated an outlicensing process aimed at finding international partners to market our products outside the Nordic region. The positive results from the phase II trial will be important in our discussions with potential partners. Our goal is to have an agreement in place in the first half of 2008.”
The clinical phase II trial for K301 was a randomized, double-blind, placebo-controlled study conducted at eleven clinics in Sweden. A total of 98 patients with varying degrees of seborrheic dermatitis of the scalp were treated with one of two variants of the K301 formulation or placebo. K301 is a solution that was applied once daily for the first four weeks followed by four weeks of maintenance treatment.
The primary efficacy variable was the degree of erythema and desquamation after four weeks. The study showed that K301 was significantly more efficacious than placebo at reducing erythema and desquamation. 76 percent of patients who received the K301 formulation considered to be the most efficacious had a positive response to the treatment, compared to 40 percent for placebo. There was no difference between K301 and placebo with respect to the total number of side effects. No serious side effects were reported in any of the groups.
An estimated 5 percent of the population have 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 for 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) has started and recruitment of patients will begin September 2007. Results from the study are expected in the second half of 2008.
Contact:
Peter Wolpert, CEO
Telephone: +46 (0)8 522 307 00
Mobile: +46 (0)70 735 71 35
e-mail: peter.wolpert@mobergderma.se
For more information, please visit our website www.mobergderma.se