Biofrontera Stats Phase 3 Clinical Study Evaluating Ameluz(R)-PDT for Basal Cell Carcinoma

  Biofrontera AG Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces that patient enrollment is now complete in the Phase 3 clinical study evaluating Ameluz^®-PDT in combination with the BF-RhodoLED^® lamp for the treatment of basal cell carcinoma (BCC). This study is being conducted by Biofrontera Bioscience GmbH.

"Completing patient enrollment in this Phase 3 clinical study is an important milestone in our strategy to expand the Ameluz^® label beyond actinic keratosis (AK). As awareness about skin cancer increases, so does demand for non-surgical BCC treatments without ionizing radiation. According to the Skin Cancer Foundation, of the 5.4 million annual cases of non-melanoma skin cancer in the U.S., approximately 3.6 million, or 67%, are BCC. There is a significant unmet medical need for more effective, less invasive and cost-efficient therapies that treat BCC as well as underlying premalignancies. We look forward to sharing results from this Phase 3 study in mid-2024," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc.

"In addition to treating individual lesions, Ameluz^® is indicated by its prescribing information* for the lesion-directed and field-directed treatment of skin areas with multiple AKs. Superficial BCC is another, more severe form of neoplastic damage that such a field may carry, and inclusion into the label broadens the use of Ameluz^® in field-directed treatment, starting a new chapter of PDT for non-melanoma skin cancer", he continued.

This randomized, double-blind, placebo-controlled study aimed at enrolling 186 patients at 19 U.S. sites. With 183 patients now treated, and four more patients screened and awaiting histological results and treatment, the clinical sites have been informed that the enrollment is complete. Each patient had one or more clinically and histologically confirmed superficial BCC. Patients receive one cycle of two PDTs (either Ameluz^®-PDT or placebo-PDT) 1-2 weeks apart, which may be repeated after three months if required. The last assessment of the patient will take place three months after the final PDT cycle. The primary endpoint is the composite complete clinical and histological clearance of a main BCC lesion, which was selected at the beginning of the study. In addition, data on drug safety as well as secondary efficacy parameters of all BCCs will be evaluated. After completion of the trial, patients will be followed for an additional five years.

https://www.biospace.com/article/releases/biofrontera-inc-announces-last-patient-enrolled-in-phase-3-clinical-study-evaluating-ameluz-r-pdt-for-the-treatment-of-basal-cell-carcinoma/