Moberg Derma reports promising phase III clinical results for its product candidate K301 against seborrheic dermatitis
8/18/2008 2:00 AM EST
Moberg Derma is today reporting promising results from a phase III study for K301 against seborrheic dermatitis. The study showed that K301 was significantly superior to placebo for several key efficacy endpoints, including a marked effect on the degree of scaling after two and four weeks of treatment. Both the patient’s and the doctor’s global assessment of the treatment efficacy were clearly in favor of K301. No serious adverse events were reported and no patient discontinued treatment due to an adverse event.
In the phase III study a significant effect on erythema could not be demonstrated leading to that the compound degree of erythema and scaling after four weeks of treatment (the primary efficacy endpoint) did not attain statistical significance. Nonetheless, an analysis of the pooled results from the phase II and phase III studies showed statistically significant differences in favor of K301 for the primary efficacy endpoint, as well as for most other efficacy endpoints.
”The results of the phase III study are in line with the positive results reported from the phase II study and provide additional support that K301 is an effective and safe treatment for seborrheic dermatitis,” comments Moberg Derma’s CEO, Peter Wolpert.”
”We are committed to the K301 program and are now intensifying our plans for commercialization and discussions with potential distribution partners, who have shown considerable interest in our product portfolio to date,” says Peter Wolpert.
The phase III clinical study of K301 was a randomized, double-blind and placebo-controlled study conducted at 21 clinics in Sweden during the first six months of 2008. A total of 201 patients with mild to moderate degrees of seborrheic dermatitis of the scalp were treated with K301 or a placebo. K301 is a steroid-free solution that, during the study, was applied to the affected area on the scalp once daily for four weeks.
Approximately 5% of the population suffers from seborrheic dermatitis of the scalp and skin. Seborrheic dermatitis is a chronic condition in which the fungus malassezia furfur is considered to play a crucial role. There is currently no cure for seborrheic dermatitis, which means that treatment focuses on minimizing the symptoms from which the patient suffers, particularly scaling, erythema and itching. The most common treatments for seborrheic dermatitis of the scalp are anti-inflammatory treatments (for example, steroids) or antifungal treatments (for example, ketokonazol). The global eczema market is growing by an estimated 3% annually and will amount to nearly SEK 8 billion by 2010.
Moberg Derma is developing several dermatological pharmaceuticals based on the company’s patented Kaprolac® principle. A phase III study for the product candidate K101 against nail fungus (onychomycosis) is under way and the results are expected at the beginning of 2009.