Biofrontera Inc. provided an update on the patient recruitment for the phase III clinical study for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz® photodynamic therapy (Ameluz®-PDT) in combination with the BF-RhodoLED® lamp in the U.S. To date, 70% of the planned 186 patients have been enrolled in the study. Patient recruitment for this study has been ongoing since 2018 with completion of patient recruitment anticipated by the end of 2022. This randomized, double-blind and placebo-controlled study will include 186 patients at 12 study sites in the United States.

Each patient will have one or more clinically and histologically confirmed superficial BCC. Patients will receive one cycle of two PDTs 1-2 weeks apart, which may be repeated after three months if required. The last assessment of the patients will take place three months after the last PDT cycle.

After completion of the trial, Biofrontera will follow patients for an additional 5-year period. Each patient will be treated with Ameluz®-PDT or placebo-PDT. The primary study endpoint is the composite complete clinical and histological clearance of a main sBCC lesion, which will be selected at the beginning of the study.

In addition, data on drug safety as well as secondary efficacy parameters of all sBCCs will be evaluated in the study. This phase III clinical study, as well as two other clinical studies currently being performed by Biofrontera AG and its Germany-based subsidiaries (together the “Licensor”), focuses on optimizing and expanding the market positioning of the Company's in-licensed FDA-approved prescription drug Ameluz® for PDT in the United States. Within the scope of the license and supply agreement (LSA) between Biofrontera Inc. and the Licensor, the Company holds the exclusive rights to market and sell Ameluz® and the PDT-lamps BF-RhodoLED® as well as the new RhodoLED® XL in the United States.

Under the terms of the LSA, Biofrontera Inc. purchases Ameluz® from the Licensor for a transfer fee. In exchange for the transfer fee paid for the in-licensed products, the Licensor ensures the manufacturing and the supply of the products as well as responsibility for certain other aspects such as regulatory approvals and quality assurance. In addition, the LSA calls for the Licensor to perform and finance an extensive clinical study program to expand the FDA-approval of Ameluz® in the U.S. market.