Biofrontera Inc. announced positive topline results from its non-randomized, open-label, multicenter Phase 1 study evaluating the safety and tolerability of 3 entire tubes of BF-200 ALA (Ameluz®) in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy using the RhodoLED® XL lamp. Of the 100 patients treated in 9 participating clinical centers, the incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information (US PI) that are based on studies with 1 tube. The treatment was generally well tolerated and TEAEs were as expected due to the therapeutic principle of photodynamic therapy.

All TEAEs were transient. In most cases, they resolved within 1 to 4 days after PDT, but occasionally persisted for 1 to 2 weeks or in a few cases even longer, similar to the TEAEs observed after single-tube PDT. No Serious Adverse Events (SAEs), deaths or other clinically relevant AEs were reported during the study and no subject discontinued the study due to a TEAE.

With results demonstrating no additional safety or tolerability issues with 3 tubes, Biofrontera Inc. intends to present these findings to the U.S. Food and Drug Administration during the fourth quarter of this year. This Phase 1 study, conducted by Biofrontera Bioscience GmbH, follows a maximal-usage pharmacokinetics study presented to the FDA in 2021, upon which the FDA requested another safety study focusing on transient side effects before amending the product information, which currently limits use to one tube of Ameluz® per treatment. Additionally, following Biofrontera Inc.'s recent announcement of completed patient enrollment in the Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED® lamp for the treatment of basal cell carcinoma, all patients in screening at the time have now been randomized.

The study is now treating 187 patients, which is one patient more than agreed upon with the FDA. The last patient to complete the final assessment, which occurs three months after their final PDT, is expected in the first quarter of 2024.