Biofrontera Locks Database For Phase 1 PK Study Of Ameluz® PDT Evaluating 240 cm² Treatment Fields Ahead Of Planned 2026 sNDA For Expanded AK Indication

Biofrontera Inc., a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT), announced that it has completed the database lock for its Phase 1 pharmacokinetic (PK) study evaluating Ameluz topical gel for treating mild to moderate actinic keratoses (AKs) on the neck, trunk, and extremities. The database was officially locked on February 11, 2026, marking a key milestone in the Company’s clinical development program.

The Phase 1 study was non-randomized and open-label, designed to evaluate how the body absorbs and processes 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) when Ameluz is used under maximal treatment conditions. Patients received photodynamic therapy using the Ameluz gel together with the red-light BF-RhodoLED XL lamp. To simulate maximum exposure, the study involved applying three full tubes of the gel to an approximately 240 cm² treatment area. The research objective was to measure systemic exposure to ALA and PpIX during and after treatment, helping determine whether the expanded use of Ameluz affects absorption levels.

Seventeen patients participated in the study and received a single PDT treatment. Following application, their plasma levels of ALA and PpIX were monitored over a 10-hour period. These measurements will contribute to a clearer understanding of the drug’s pharmacokinetic behavior when treating larger areas of skin than currently approved.

The PK findings, together with previously reported positive Phase 3 results for Ameluz PDT on the extremities, neck, and trunk, are expected to support a supplemental New Drug Application to the U.S. Food and Drug Administration. Biofrontera plans to submit the application in the third quarter of 2026. The goal is to expand the product’s existing label, which currently permits treatment of up to 60 cm² of AK on the face and scalp, to allow treatment fields of up to 240 cm² on additional sun-exposed body regions.

Hermann Luebbert, CEO and Chairman of Biofrontera Inc., stated that locking the study database marks an important advance for the Company’s clinical efforts. He noted that the PK data, combined with the strong Phase 3 results, are intended to support expanding the approved use of Ameluz PDT beyond its current indication. If the label expansion is approved, healthcare providers may be able to treat larger, more burdensome AK areas on regions other than the face and scalp. Luebbert emphasized that this would further enhance the clinical positioning of Ameluz and support its long-term growth trajectory.