• First Phase 3 PDT study in patients with sBCC in the United States.
• Rigorous dual endpoints requiring complete clinical and cytological clearance of malignant lesions.
• Data now being analyzed, interim results expected November 2024.
• BCC is the most common skin cancer in the US with more than 3 million cases each year¹.

Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), announced today that the database for the treatment phase of study ALA-BCC-CT013 has been locked.

The database lock is an important milestone in the lifecycle of a clinical trial, marking the end of data collection and the point at which no further changes can be made to the trial database. The clinical data are now ready for final analysis.

This Phase 3 trial is to evaluate the safety and efficacy of Ameluz^®-PDT in combination with the BF-RhodoLED^® lamp for the treatment of sBCC. It is a double-blind, randomized, placebo-controlled multi-center study involving 186 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 is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were evaluated.

In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for Q1 2025.

“If this indication is granted by the FDA this would expand our label from premalignant application for Actinic Keratoses to the treatment of cutaneous malignancy. It would be the next stage in our continued development of PDT and part of our vision to become the market leaders in this field” stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc.