COPENHAGEN, Denmark, October 24 /PRNewswire/ -- Astion Pharma A/S has started recruiting patients suffering from seborrheic dermatitis in a phase 2B study with ASF-1057. ASF-1057 is a potent anti-inflammatory product candidate, for which human proof of concept has already been established. Seborrheic dermatitis affects 3-5% of the population.
This trial is the first in a series of 3 clinical studies to evaluate the effect of ASF-1057 in various doses and formulations. In total 264 patients will be enrolled in these 3 trials.
The study is a double blind, placebo controlled trial. It is being conducted at a clinical center in Lyon, France. 104 patients suffering from moderate to severe seborrheic dermatitis will be treated once a day for three weeks with one of three different treatment doses of ASF-1057 or placebo. The effect will be rated according to clinical signs and symptoms, i.e.: erythema and scaling.
An additional study with a similar design will be initiated in Paris later this year. This study involves 60 patients being treated twice daily for three weeks with two doses of ASF-1057 or placebo. Finally, a study including 100 patients will be initiated in the UK early 2007. The results of all three studies are expected in 2007. The purpose of this phase 2B program is to establish the optimal dosing regimen for ASF-1057 and to form the basis for moving the project into phase 3 clinical development. Astion plans to start phase 3 clinical studies in Europe in 2007, while seeking a development partner for the North American markets.
The phase 2B program follows a positive phase 2A proof of concept study in which ASF-1057 showed a remarkably strong anti-inflammatory effect in seborrheic dermatitis. 93% of patients treated with ASF-1057 twice a day for three weeks responded and were free or almost free from symptoms. The same response rate in the placebo group was 40%. The difference between ASF-1057 and placebo was highly statistically significant.
ASF-1057 has a unique pharmacodynamic profile inhibiting multiple inflammatory processes involved in seborrheic dermatitis. ASF-1057 is formulated as a moisturizing cream for application to the face and chest.
Seborrheic dermatitis is a common dermatological disease which, in many cases, causes an inflammatory reaction to the fungus malassezia furfur in the skin. The exact cause is not fully understood. Clinically, seborrheic dermatitis is characterized as a red, greasy and scaly eczema, typically occurring on the face and chest and/or the scalp. The prevalence is normally estimated to be 3-5%, although the disease is probably much more common in reality. More men than women are affected. Age at onset varies from the teens to the 40s.
Astion Pharma A/S develops pharmaceutical products for the treatment of skin diseases. It is estimated that one person in four worldwide will suffer from a skin disease sometime in life, causing a deterioration of their quality of life. It is the Company's goal to become a leading player in the treatment of skin diseases for which there is currently a major need for new and better therapies. Astion Pharma has a strong platform of proprietary technologies for the development of new and innovative products. The Company pursues development activities through a strong international network of scientific partners and leading contract research organisations. The Company currently has three development projects in Phase 2 clinical studies in Hand Dermatitis, Seborrheic Dermatitis and Cutaneous Lupus in addition to a large portfolio of product candidates and research programmes in earlier phases. For additional information please visit our web site: www.astion.com.
Astion Pharma A/S