Peplin reports positive results from Phase IIb actinic keratosis trial

As in previous trials, this study has reportedly demonstrated a clear dose response relationship with four out of the six treatment groups achieving statistically significant clearance of AK lesions when compared with vehicle. The complete clearance rates ranged from 15.6% to 42.3% across the six active treatment groups. At all concentrations, for both the two day and three day treatments, the PEP005 Gel demonstrated a favorable safety profile and was well tolerated, the company said.

In the highest treatment group (0.015% PEP005 Gel for three consecutive days) the complete clearance rate (primary efficacy endpoint) was 42.3% (p=0.005 compared to vehicle) and the median reduction in lesion count was 84.5%.

PEP005-015 was an eight-arm, 240-patient, US and Australian multi-centre, randomized, double-blind, vehicle-controlled, dose-ranging clinical trial. It was designed to evaluate the safety and efficacy of each of three concentrations (0.005%, 0.010% or 0.015%) and two treatment regimens (once a day for two or three consecutive days) for Peplin’s patented product, PEP005 Gel in patients with AK lesions on the head when used as field-directed therapy.

Following an end-of-phase II meeting with the FDA, Peplin plans to initiate a subsequent Phase III clinical trial for patients with AK lesions on the head in 2009.

Tom Wiggans, Peplin’s CEO, said: The data are consistent with prior trials and will allow us to select both a dose and regimen for our Phase III development which would make PEP005 Gel, if approved, a very important new product for the treatment of AK. As no current product on the market has a short course of therapy and proven efficacy for both head and non-head lesions, the potential value that PEP005 Gel offers patients is considerable.