Ameluz Demonstrates High Efficacy in Phase 3 Trial for Superficial Basal Cell Carcinoma
Key Insights
Biofrontera's Ameluz-PDT achieved a 65.5% success rate in complete clearance of sBCC (search) lesions, significantly outperforming placebo at 4.8%.
The Phase 3 study met all primary and secondary endpoints with high statistical significance (p<0.0001), mirroring positive results from European studies.
Ameluz-PDT showed complete histological clearance in 75.9% of lesions and clinical clearance in 83.4% of patients, compared to 19.0% and 21.4% with placebo, respectively.
Biofrontera Inc. has announced highly significant results from its Phase 3 study evaluating Ameluz® in photodynamic therapy (PDT) for superficial basal cell carcinoma (search) (sBCC (search)). The study, ALA-BCC-CT013, demonstrated that Ameluz®-PDT, when used with the BF-RhodoLED® lamp, achieved a notably higher success rate compared to placebo in treating sBCC.
The double-blind, randomized, placebo-controlled, multi-center trial involved 187 patients with clinically and histologically confirmed sBCC (search). Patients received one cycle of two PDT treatments (Ameluz®-PDT or placebo-PDT) spaced 1-2 weeks apart, with a potential repeat after three months if needed.
The primary endpoint, a composite of complete clinical and histological clearance of a preselected main target BCC lesion, was met by 65.5% of patients (95/145) in the Ameluz®-PDT group, compared to only 4.8% (2/42) in the placebo group (p<0.0001). Complete histological clearance was observed in 75.9% (110/145) of lesions treated with Ameluz®, versus 19.0% (8/42) with placebo. Clinical clearance rates were 83.4% (121/145) for Ameluz® and 21.4% (8/42) for placebo. Secondary efficacy parameters also showed highly significant results (p<0.0001), with 64.1% of Ameluz®-PDT patients achieving total clearance of all sBCC (search) lesions, compared to 4.8% in the placebo group. Patient satisfaction was high, with most Ameluz®-PDT recipients rating overall treatment satisfaction and esthetic outcome as very good (64.3%) or good (22.2%).
Expert Commentary
"We are delighted that these highly significant results mirror those found in the European studies," stated Dr. Hermann Luebbert, CEO and Chairman of Biofrontera. He added, "Once we finish the one-year follow up phase in December, we will be in a position to submit our dossier to the FDA around the end of Q2 / early Q3 of 2025."
Dr. David Pariser, Coordinating Investigator for the study, noted, "I have used Ameluz®-PDT in my practice for many years for the treatment of Actinic Keratosis, and we were pleased to be a part of such an extensive and rigorous study to examine its use in patients with superficial BCC."
Impact on Treatment Landscape
Dr. Todd Schlesinger, a board-certified dermatologist and Mohs surgeon, commented, "I am excited that the potential FDA approval may provide me with a new non-invasive option for my patients that may not involve potential scarring, or repeated office visits for ionizing radiation, and which could therefore lead to reduced patient burden and a beneficial cosmetic outcome."
About Basal Cell Carcinoma
Basal cell carcinoma (search) is the most common form of skin cancer, with approximately 3.6 million cases diagnosed annually in the U.S. BCCs originate from uncontrolled growth of basal cells in the epidermis. While rarely spreading beyond the original site, untreated BCC can become locally invasive, damaging skin, tissue, and bone.