Leo Pharma Presents Positive Results For Phase III Actinic Keratosis Trials

Leo Pharma has reported positive results for the two phase III actinic (solar) keratosis (AK) clinical trials using PEP005 (ingenol mebutate) gel. It is meant for the treatment of lesions on head treatment areas, which include the face and scalp.

The trials were initiated and run by US and Australia-based Peplin, acquired by Leo Pharma in the fall of 2009. Both the phase III trials achieved their primary and secondary efficacy endpoints with statistically significant clearance of AK lesions vs vehicle.

The two completed phase III clinical trials, known as Region-IIa and Region-IIb, enrolled approximately 250 patients each and evaluated the use of a 0.015% concentration of PEP005 gel applied daily for three consecutive days to AK lesions on the face and scalp.

Lars Olsen, executive vice president for research & development at Leo Pharma, said: “The strong results from the trials are an important step towards a unique and novel treatment model for AK. The results are also an important step in Leo Pharma’s growth strategy. The trials confirm the results of prior trials and we are closer to being able to provide the patients a 3-day course of therapy than ever.

“The Peplin team has done an excellent job of executing the development program and completing the Phase III trials within the expected timeframe. We are happy to have confirmed the basis for a novel, competitive product, even if we still have some way to go.”

LEO Pharma has one additional phase III clinical trial currently ongoing with PEP005 gel for AK lesions. This trial, known as Region-Ib, is for lesions on non-head locations, which includes the trunk and extremities, and was designed to replicate the previously completed, successful Region-I trial and confirm its results. Region-Ib has completed enrollment of approximately 250 patients earlier this year and data is expected by the end of Q1, 2010.