On February 1, 2022 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported that it is making progress in patient recruitment of its US phase III clinical study to investigate the treatment of superficial basal cell carcinoma (sBCC) with photodynamic therapy (PDT) using Ameluz in combination with BF-RhodoLED (together, Ameluz-PDT) (Press release, Biofrontera, FEB 1, 2022, View Source [SID1234607557]). To date, 70% of the planned 186 patients have been enrolled in the study with completion of patient recruitment anticipated by the end of 2022.

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Patient recruitment for this study has been ongoing since September 2018. Due to the demanding study protocol mandated by the FDA, patient recruitment has been slower than anticipated and was additionally decelerated by the pandemic. However, patient recruitment has recently picked up again. Following successful FDA approval, Ameluz would be the only drug in the United States for the treatment of sBCC with PDT.

As a reminder, Ameluz-PDT is approved in the European Union for the treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment since January 2017.