Solna, Sweden--The Swedish pharmaceutical company Moberg Derma, which focuses on skin diseases, has finalized patient recruitment for a clinical phase III trial of the K101 product candidate to treat nail fungus (onychomycosis). The recruitment of patients has been finalized faster than expected and the study will include over 500 patients at 40 clinics in Sweden and Poland. Results from the trial are expected in the second half of 2008.
”We are positively surprised by the great interest among patients to participate in the study” says the company’s Medical Director, Kjell Rensfeldt. ”This confirms that there is a considerable need for new treatment alternatives for nail fungus and that the disease today is under treated.”
K101 is a pharmaceutical for the topical treatment of nail fungus that is applied once daily to the infected nail. In an earlier study of 58 infected nails with severe nail fungus, 31 percent of the nails were completely cured and an additional 56 percent were distinctly improved after treatment for six months. A complete cure was defined as clinical and mycological cure.
Nail fungus is caused by dermatophytes, mainly trichophyton rubrum, and affects an estimated 8 percent of the population. Since many patients do not seek treatment, the hidden prevalence is thought to be even higher. The most common treatments for nail fungus are oral terbinafine or topical treatment with amorolfine. There is a great need for new and effective topical treatments with an attractive side-effect profile. The global market for anti-fungal dermatological products is expected to grow by 6 percent per year to reach nearly 4 billion USD by 2010.
Moberg Derma is developing several dermatological products based on the patented Kaprolac® principle. The company has today also reported that it has started recruiting patients for a clinical phase III trial for its K301 product candidate to treat seborrheic dermatitis of the scalp. Results from the study are expected in the second half of 2008.
Contact: Peter Wolpert, CEO Telephone: +46 (0)8 522 307 00 Mobile phone: +46 (0)70 735 71 35 E-mail: peter.wolpert@mobergderma.se
Kjell Rensfeldt, Medical Director Telephone: +46 (0)8 522 307 00 Mobile: +46 (0)70 - 712 45 32 E-mail: kjell.rensfeldt@mobergderma.se
For more information, please visit our website www.mobergderma.se
About Moberg Derma Moberg Derma AB develops dermatological products to treat common skin diseases. The company has two products in phase III – K101, a topical treatment for nail fungus and K301, a non-steroid treatment for seborrheic dermatitis of the scalp. Moberg Derma intends to out license the rights to Kaprolac® in markets outside the Nordic region. The company was formed in March 2006 with the objective of commercializing products based on the Kaprolac® principle invented by Dr. Sven Moberg, a Swedish specialist in dermatology and mycology. Dr. Moberg worked for 15 years developing treatment methods for common skin diseases that are difficult to treat. His work has resulted in two patent families and more than ten product candidates. The company’s patent rights also cover cosmeceuticals and products for chemotechnical applications.
The Kaprolac® principle Kaprolac® is a composition of well-documented dermatological compounds providing important therapeutic benefits. Kaprolac® has a potent antimicrobial effect as well as keratolytic and moisturizing properties. The components are environmentally friendly and have an excellent safety profile.
