Patient Recruitment Finalized to Moberg Derma’s Clinical Phase III Trial for its K101 Product Candidate to Treat Nail Fungus (Onychomycosis)
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.