Biofrontera Significant Results In Phase 3 for Treatment Of Superficial Basal Cell Carcinoma

 

• First Phase 3 PDT study in patients with sBCC in the United States.
• Primary and secondary endpoints all highly statistically significant p<0.0001
• Correlates to data seen in Europe where sBCC is already incorporated in the Summary of Product Characteristics.
• BCC is the most common skin cancer in the US, with more than 3 million cases each year

The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz®-PDT or placebo-PDT) 1-2 weeks apart, repeated after three months, if required.

The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. Ameluz®-PDT achieved 65.5% success (95/145 subjects) in this rigorous target, compared to 4.8% success (2/42 subjects) achieved with placebo-PDT (p<0.0001). Complete histological clearance was seen in 75.9% (110/145) of these lesions in the Ameluz® arm, compared to 19.0% (8/42) with placebo. Complete clinical clearance was achieved in 83.4% (121/145) of patients treated with Ameluz® compared to 21.4% (8/42) with placebo. The results for all other secondary efficacy parameters were equally highly significant (p<0.0001) with, for instance, 64.1% of Ameluz®-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT. Most patients who received Ameluz®-PDT rated the overall treatment satisfaction and esthetic outcome as very good (64.3%) or good (22.2%).”

https://www.globenewswire.com/news-release/2024/10/31/2972788/0/en/Biofrontera-Inc-Announces-Highly-Significant-Results-In-Phase-3-Study-Of-Ameluz-Photodynamic-Therapy-PDT-Regarding-The-Treatment-Of-Superficial-Basal-Cell-Carcinoma-sBCC.html