Biofrontera Inc. (Nasdaq: BFRI) (the “Company”), a biopharmaceutical company specializing in the commercialization of dermatological products, is pleased to provide 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.
“Due to a demanding study protocol mandated by the FDA, the recruitment process has been taking a considerable amount of time and was additionally slowed down by the Covid pandemic, but has recently picked up again”, said CEO Erica Monaco. “Following successful FDA approval, Ameluz® would be the only drug in the United States approved for the treatment of superficial BCC with PDT, which we expect to further increase the growth potential of our flagship product Ameluz® in the medium term. “
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.
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