LEO Pharma presents Phase III study results of PEP005 Gel 0.05% for treatment of AK at 68th AAD meeting

Specialty pharmaceutical company LEO Pharma today announced that findings from a Phase III study evaluating PEP005 (ingenol mebutate) Gel 0.05% to treat actinic keratosis (AK), a common pre-cursor to skin cancer, were presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) (Scientific Session Poster Discussion: P105).  Results from REGION-I demonstrated treatment with PEP005 Gel once daily for 2 consecutive days.

"Cryotherapy has been the gold standard for actinic keratosis for some time, with topical agents also used over a period of weeks to months.  Findings from the REGION-I study suggest that PEP005, a topical Gel administered over just two days, may provide a safe and effective alternative to current therapies," said Neil Swanson, M.D., Department Chairman and Professor of Dermatology, Surgery and Otolaryngology at Oregon Health & Sciences University, and REGION-I principal investigator.

Patients in REGION-I were randomized to receive either PEP005 Gel applied topically as monotherapy to body AK lesions once daily for 2 consecutive days or vehicle. Patients were evaluated on days 3, 8, 15, 29 and 57. The primary objective was to compare the efficacy, as measured by complete clearance, of PEP005 Gel with the vehicle. The secondary objective was the partial clearance of AK lesions. Safety was also assessed by the incidence rate of adverse events (AEs) serious adverse events (SAEs) and AEs leading to discontinuation, as well as by the incidence rate and grade of Local Skin Responses (LSRs), pigmentation and scarring.

The REGION-I study showed PEP005 Gel significantly cleared AK lesions across all anatomical non-head sites at day 57, with complete clearance observed in 32 (27.4%) patients treated with the 0.05% dose vs. 6 (5.1%) in the vehicle group>

PEP005 (ingenol mebutate) Gel at AAD

Phase II data evaluating the safety and efficacy of PEP005 in both head and non-head locations were included in AAD poster sessions:

• Multicenter, randomized, double-blind, vehicle-controlled, dose-ranging study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) Gel, 0.005%, 0.01%, and 0.015% when used to treat actinic keratoses (AK) on the head.

P2913: Electronic Poster

• Multicenter, open-label, dose-area escalation, cohort study to evaluate the safety and tolerability of PEP005 (ingenol mebutate) Gel, 0.05% applied for 2 consecutive days to treatment area(s) of up to a total of 100 cm2 in patients with actinic keratoses (AK) on the extensor (dorsal aspect) forearm(s).