Biofrontera Inc. (Nasdaq: BFRI) has announced the database lock for its Phase 3 study, ALA-BCC-CT013, evaluating the safety and efficacy of Ameluz®-PDT in combination with the BF-RhodoLED® lamp for treating superficial basal cell carcinoma (sBCC). This milestone marks the completion of data collection, allowing for final analysis of the clinical results.
The Phase 3 trial is a double-blind, randomized, placebo-controlled, multi-center study conducted in the United States, involving 186 patients with clinically and histologically confirmed sBCC. Participants received one cycle of two PDT treatments (Ameluz®-PDT or placebo-PDT) spaced 1-2 weeks apart, with the option to repeat the cycle after three months if needed. The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were also evaluated.
Expanding Treatment Options for sBCC
Basal cell carcinoma (BCC) is the most common form of skin cancer in the U.S., with over 3 million cases diagnosed annually. Superficial BCC represents a significant portion of these cases, often presenting as slow-growing lesions on sun-exposed areas of the body. Current treatment options include surgical excision, cryotherapy, and topical medications. Ameluz®-PDT offers a non-invasive alternative that could be particularly beneficial for patients with multiple lesions or lesions in cosmetically sensitive areas.
Regulatory Pathway and Future Plans
In addition to the final study report, the FDA requires the submission of follow-up data obtained one year after the first PDT treatment. The last patient is expected to complete this follow-up by December of this year, with the submission targeted for Q1 2025.
"If this indication is granted by the FDA this would expand our label from premalignant application for Actinic Keratoses to the treatment of cutaneous malignancy. It would be the next stage in our continued development of PDT and part of our vision to become the market leaders in this field," stated Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc.
About Ameluz® and Photodynamic Therapy
Ameluz® is a topical prescription drug used in photodynamic therapy (PDT) in conjunction with the BF-RhodoLED® lamp. It is currently approved for the treatment of actinic keratoses (AK), precancerous skin lesions that can develop into squamous cell carcinoma if left untreated. In 2020, approximately 58 million people in the US were affected by AK, leading to 13 million AK treatments.
