LEO Pharma’s PEP005 meets endpoint in Phase III trial
Ballerup – Danish dermatology specialist LEO Pharma announced yesterday that its topical treatment PEP005 (ingenol mebutate) for actinic keratosis (AK) has met the primary endoint of of complete clearance of body AK lesions in a Phase III clinical trial. AK is a pre-cancerous skin condition that if left untreated, can lead to the development of skin cancer. According to the American Academy of Dermatology, 40 percent of cases of squamous cell carcinoma begin as AK. Approximately 250 patients were enrolled in the study, which evaluated the use of a 0.05% concentration of PEP005 Gel applied daily as monotherapy for two consecutive days to AK lesions on non-head locations. PEP005 Gel demonstrated a favorable safety profile, was well tolerated and had side effects consistent with those seen in Phase II studies, according to the company. LEO Pharma expects to file for regulatory approval of the treatment in the U.S. and Europe in 2011. The news follows the results of a head-to-head study that compared efficacies of the current treatment, standard Metvix, with German company Biofrontera’s photodynamic therapy plus BF-200 ALA (5-aminolevulinic acid in Biofrontera’s proprietary nanoemulsion BF-200). Results reported that BF-200 ALA, on average, erased all lesions in 78% of the patients, whereas Metvixonly reached a complete healing rate of only 64%, and the placebo group 17%. Biofrontera will file for registration this summer.