Biofrontera Inc. Reaches Key Milestone in Phase 3 Ameluz®-PDT Study for sBCC Treatment

Biofrontera Inc., a U.S.-based biopharmaceutical company, has reached a significant milestone in its Phase 3 clinical trial evaluating the use of Ameluz and RhodoLED photodynamic therapy (PDT) for treating superficial basal cell carcinoma (sBCC). In December 2024, the final patient completed a one-year follow-up visit as part of study ALA-BCC-CT013. This study, which is essential for the company's forthcoming submission to the U.S. Food and Drug Administration (FDA), involved 187 patients with clinically and histologically confirmed sBCCs. Each participant received a cycle of two PDT treatments, administered one to two weeks apart, using either Ameluz-PDT or a placebo. Lesions that did not fully resolve within three months received additional treatment.

The FDA has advised Biofrontera to include one-year follow-up data in their submission, which is expected in the third quarter of 2025. However, the study will continue to monitor the patients’ lesions for a total of five years. This extended observation is crucial for evaluating long-term treatment efficacy and safety, particularly due to the risk of local recurrence or the emergence of additional skin cancers in sBCC patients.

In October 2024, Biofrontera disclosed that the study achieved highly statistically significant results in all primary and secondary endpoints, with a p-value of less than 0.0001. These findings have been pivotal for the company as it aims to expand the therapeutic label to include sBCC treatment. Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., highlighted that the completion of the one-year follow-up marks a significant step toward FDA submission in 2025, reinforcing the company's commitment to advancing PDT in dermatology to enhance patient care.

Dr. Shane Chapman, Chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and an investigator in the study, expressed optimism about the study outcomes. He noted the routine use of PDT for treating actinic keratoses at their institution and anticipated the inclusion of Ameluz-PDT as a treatment option for sBCC patients.

Basal cell carcinoma (BCC) is the most prevalent form of skin cancer and the most frequently diagnosed cancer overall. In the United States, approximately 3.6 million cases are identified annually, a portion of which is superficial basal cell carcinoma. BCC originates from the uncontrolled proliferation of basal cells located at the base of the epidermis. While these cancers seldom metastasize beyond the initial tumor site, neglecting treatment can result in local invasion, leading to significant skin, tissue, and bone damage.

Biofrontera Inc. focuses on developing and commercializing PDT for dermatological conditions. The company markets the Ameluz® drug-device combination with the RhodoLED® lamp series for treating actinic keratoses, which are pre-cancerous skin lesions that might progress into invasive skin cancers. Additionally, Biofrontera is conducting clinical trials to broaden the scope of its products to address non-melanoma skin cancers and moderate to severe acne.