German BfArM grants Moberg Derma approval to initiate Limtop phase II actinic keratosis trial

The German Federal Institute for Drugs and Medical Devices (BfArM) has granted Moberg Derma (STO:MOB) approval to initiate a clinical phase II trial for Limtop. The aim is to evaluate the efficacy and safety of three different dose regimens of Limtop in a study involving 96 patients with Actinic Keratosis (AK) on the head or face. The results are expected in the first half of 2013. The approval was granted following positive results from a phase I study on 30 healthy volunteers who were treated daily for 21 days. No serious treatment-related adverse events were observed.

Limtop is an innovative formulation of imiquimod to treat actinic keratosis, genital warts and basal cell cancer. The objective is a product with short treatment duration, an improved safety profile and an efficacy similar to or better than that of competing preparations.

"Limtop has the potential to make a real difference for many patients who currently suffer significant side effects, and we look forward to evaluate this novel formulation in actinic keratosis patients", says Peter Wolpert, CEO and founder of Moberg Derma.