Biofrontera Inc. to launch Phase 3 study of Ameluz-PDT

Biofrontera announced the launch of a randomized, double-blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz and BF-RhodoLED XL in the field-directed treatment of actinic keratosis on the extremities, neck and trunk. The study is being managed by Biofrontera Bioscience GmbH. This past weekend Biofrontera held an Investigator Meeting to train clinical investigators on the protocol for this photodynamic therapy study and prepare for site initiation. Initially 11 clinical trial sites in the U.S. will participate, enrolling approximately 165 patients stratified by body region. This study will utilize Biofrontera's new RhodoLED XL, a red-light lamp approved by the U.S. Food and Drug Administration for use in PDT in combination with Ameluz for the treatment of mild-to-moderate actinic keratosis. This lamp allows for the illumination of a larger surface area, thereby enabling simultaneous treatment of AK lesions that are distant from one another. Patients enrolled in this study will have 4-15 mild-to-moderate AK lesions in the treatment field. Each will be treated once with Ameluz-PDT and upon a three-month evaluation, will be treated a second time if any lesions remain. Investigators will continue to follow patients for 12 months after their most recent treatment to monitor for any recurrences or new lesions, as well as for any adverse events. The primary endpoint is total clearance of all lesions three months after the most recent treatment. Secondary endpoints are total clearance of all lesions three months after the last treatment by body region, percentage of all lesions cleared overall and percentage cleared by body region and severity.