Peplin Initiates Phase 3 Trial For Ingenol Mebutate Gel

Peplin has initiated the second non-head phase 3 clinical trial to confirm the efficacy and safety of PEP005 (ingenol mebutate) gel, for the treatment of actinic keratoses (AK).

The second pivotal phase 3 trial for non-head locations, known as REGION-Ib, is designed to replicate the recently completed REGION-I trial and confirm the results of PEP005 gel.

REGION-Ib is a randomised, double-blind, vehicle-controlled clinical trial. Peplin expects to enroll approximately 200 patients, who will self-apply the study medication (0.05%) or vehicle gel for two consecutive days to a 25cm2 treatment area containing four to eight AK lesions.

The primary efficacy endpoint for the REGION-Ib trial would be the complete clearance rate of AK lesions. The secondary efficacy endpoint would be the partial clearance rate of AK lesions within the treatment area. Peplin will also measure the overall median reduction of AK lesions.

Peplin expects to complete the phase 3 clinical trials for AK by the end of this year, and plans to file a New Drug Application in mid-2010.

Tom Wiggans, CEO of Peplin, said: “Achieving this additional milestone immediately following the rapid enrolment in our Phase 3 head trials, demonstrates our commitment to progressing PEP005 gel through the final phase of our clinical development process. Based on the data we generated in the REGION-I trial, we believe PEP005 gel with its short course of therapy represents a significant advance in the treatment of a common skin condition, which if left untreated can progress to squamous cell carcinoma.”