Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz® for Actinic Keratoses on Trunk and Extremities

Core Viewpoint - Biofrontera Inc. has locked the database for its Phase 1 pharmacokinetics study of Ameluz, a topical gel for treating mild to moderate actinic keratoses, marking a significant milestone in its clinical program [1][5]. Group 1: Study Details - The Phase 1 study was non-randomized and open-label, assessing systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during photodynamic therapy (PDT) with Ameluz and the BF-RhodoLED XL lamp [2]. - The study involved 17 patients who received a single PDT treatment with Ameluz, with plasma concentrations of ALA and PpIX measured over a 10-hour period post-application [3]. Group 2: Regulatory and Market Implications - The pharmacokinetics data from this study, along with previously announced positive Phase 3 results, are intended to support a supplemental New Drug Application (sNDA) to the FDA for expanding the current label [4]. - The sNDA submission is expected in Q3 2026, aiming to extend the treatment indication from a 60 cm field on the face and scalp to a 240 cm field on other body parts [4][9]. Group 3: Company Overview - Biofrontera is a biopharmaceutical company focused on dermatological conditions, particularly through photodynamic therapy, and commercializes Ameluz in combination with the RhodoLED lamp series for treating actinic keratosis [7]. - Actinic keratosis is the most common pre-cancerous skin lesion caused by chronic sun exposure, affecting approximately 58 million people in the U.S. as of 2020, with 13 million treatments performed that year [6].