Moberg Derma Starts Recruiting Patients for Phase III Clinical Trial for Its K101 Product Candidate to Treat Nail Fungus (Onychomycosis)

The Swedish pharmaceutical company Moberg Derma, which focuses on skin diseases, has started recruiting patients for a clinical phase III trial of the K101 product candidate to treat nail fungus (onychomycosis). The company plans to include 470 patients in the study at around 40 clinics in Sweden and Poland. Results from the trial are expected in the second half of 2008.

”This is Moberg Derma’s first clinical phase III trial and a big step for the company,” says the company’s CEO, Peter Wolpert. ”If data from earlier trials can be reproduced in this larger study, we will be able to offer patients a topical treatment for nail fungus that compares favorably to current oral treatments without the side-effects associated with these.”

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. 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, 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 almost 4 billion USD by 2010.

Moberg Derma is developing several dermatological products based on the patented Kaprolac® principle. The company has today also reported positive phase II data for its K301 product candidate for the treatment of seborrheic dermatitis of the scalp.


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