Biofrontera Reports Major Phase 3 Results for Ameluz®-PDT in Treating sBCC

Biofrontera Inc. recently shared top-line outcomes from its Phase 3 study, code-named ALA-BCC-CT013, which assessed the efficacy and safety of Ameluz® combined with the BF-RhodoLED® lamp for treating superficial basal cell carcinoma (sBCC). This clinical trial was meticulously designed as a double-blind, randomized, placebo-controlled, multi-center study. It involved 187 patients diagnosed with one or more clinically and histologically confirmed sBCCs.

Participants were administered one cycle of two photodynamic therapy (PDT) treatments with either Ameluz®-PDT or a placebo, spaced 1-2 weeks apart. If necessary, this treatment cycle was repeated after three months. The study's primary goal was to achieve complete clinical and histological clearance of a preselected main sBCC lesion per patient at 12 weeks post the final PDT cycle. The results were impressive, with Ameluz®-PDT achieving a 65.5% success rate in this rigorous target (95 out of 145 subjects), compared to a mere 4.8% success rate (2 out of 42 subjects) in the placebo group, with highly significant statistical results (p<0.0001).

Secondary endpoints, like complete histological clearance, were also achieved in 56.6% of patients treated with Ameluz®-PDT, significantly higher than the 19.0% observed in the placebo group. Complete clinical clearance was recorded in 83.4% of patients receiving Ameluz®, compared to 21.4% in the placebo group. All other secondary efficacy parameters demonstrated similarly significant results.

Additionally, the study noted that the overall satisfaction and esthetic outcome were rated as very good by 64.3% of patients treated with Ameluz®-PDT, while 22.2% rated it as good. The success observed in this U.S. study aligns with previous data from Europe, where sBCC is already included in the Summary of Product Characteristics for the treatment.

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera, expressed delight in the study's results. He mentioned that after completing a one-year follow-up phase in December, the company plans to submit the necessary dossier to the FDA around the end of the second or early third quarter of 2025.

Dr. David Pariser of Virginia Clinical Research and Pariser Dermatology, who served as the Coordinating Investigator for the study, highlighted his extensive experience using Ameluz®-PDT for Actinic Keratosis and expressed satisfaction at participating in such a comprehensive study for sBCC. Dr. Todd Schlesinger, a board-certified dermatologist and Mohs surgeon, emphasized the potential benefits of FDA approval. He noted that this non-invasive treatment could reduce patient burden, eliminate the need for ionizing radiation, and provide favorable cosmetic outcomes.

Basal cell carcinoma (BCC), the most common skin cancer in the U.S., sees an estimated 3.6 million cases diagnosed annually. BCC arises from the uncontrolled growth of basal cells in the epidermis. Although these tumors rarely metastasize, untreated BCC can become locally invasive, causing significant tissue and bone damage.

Biofrontera Inc., based in the U.S., specializes in the development and commercialization of dermatological treatments, particularly focusing on photodynamic therapy. The company's product, Ameluz®, used in combination with the RhodoLED® lamp series, is primarily marketed for treating Actinic Keratosis, which can potentially progress to invasive skin cancers. Biofrontera is actively conducting clinical trials to expand the application of its products to treat non-melanoma skin cancers and moderate to severe acne.