Biofrontera Inc. (BFRI), a biopharmaceutical company specializing in photodynamic therapy or PDT, on Wednesday provided an update on its Phase 3 clinical trial for Ameluz-PDT in the treatment of superficial basal cell carcinoma or sBCC.
Superficial basal cell carcinoma (sBCC) is a common, low-risk skin cancer that affects the top layers of the skin.
Biofrontera achieved major progress with the completion of the last patient's one-year follow-up visit in December 2024 in its ALA-BCC-CT013 study.
The trial demonstrated highly statistically significant results for all primary and secondary endpoints (p<0.0001), reported in October 2024, indicating Ameluz-PDT's safety and efficacy in treating sBCC.
Data from the one-year follow-up will be included in the FDA submission, expected in the third quarter of 2025.
The trial will continue with five years of total follow-up for patients to monitor long-term outcomes.
This study, involving 187 patients, is critical for expanding Ameluz-PDT's label to treat superficial basal cell carcinoma, a common form of skin cancer with over 3 million new cases annually in the U.S.
Currently BFRI is trading at 1.23 up by 11.74%.
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