Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities

Core Insights - Biofrontera Inc. has completed the final patient visit in its Phase 1 pharmacokinetic study of Ameluz gel for treating mild to moderate actinic keratoses [1][4] - The data from this study, along with results from a recent Phase 3 clinical trial, will support a supplemental New Drug Application to the FDA to expand Ameluz's label [2][4] - Actinic keratoses are common pre-cancerous skin lesions that can progress to squamous cell carcinoma if untreated, affecting approximately 58 million people in the US as of 2020 [5] Company Overview - Biofrontera Inc. specializes in the development and commercialization of photodynamic therapy for dermatological conditions, particularly focusing on the drug-device combination Ameluz and the RhodoLED lamp series [6] - The company aims to extend the use of its products to treat non-melanoma skin cancers and moderate to severe acne [6] Clinical Study Details - The Phase 1 study evaluated the pharmacokinetic profile of 5-aminolevulinic acid and its metabolite protoporphyrin IX during Ameluz-PDT treatment on the upper extremities, neck, or trunk [3][8] - Seventeen patients participated in the study, receiving one PDT treatment with blood samples taken over 10 hours to assess systemic exposure [3] Future Plans - Pending positive outcomes from the Phase 1 and Phase 3 studies, Biofrontera plans to submit a supplemental New Drug Application to the FDA in Summer 2026 [4][8]