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Biofrontera AG: Biofrontera enrolls first patient to phase IIb clinical study evaluating Ameluz® / BF-RhodoLED® for acne
Leverkusen, Germany (pta032/13.12.2021/15:05 UTC+1)
Biofrontera AG (Frankfurt Stock Exchange: B8F; NASDAQ: BFRA) (the "Company"), an international biopharmaceutical company, is pleased to announce that it has commenced patient enrollment to its phase IIb study to evaluate the safety and efficacy of Ameluz® in combination with the red-light lamp BF-RhodoLED® in the treatment of moderate to severe acne with photodynamic therapy (Ameluz®-PDT).
"We believe that Ameluz®-PDT has the potential to expand the treatment options for millions of people suffering from moderate to severe acne in the US," says Biofrontera AG’s CEO Hermann Lübbert. "Our focus remains on expanding the FDA-approval of Ameluz® to include additional indications, thereby unlocking the full treatment and market potential of Ameluz®."
The multicenter, randomized, double blind phase II study with four arms uses conventional Ameluz®-PDT and includes 126 adult patients suffering from moderate to severe acne, which will be treated with Ameluz®-PDT or placebo. Efficacy and safety of Ameluz®-PDT will be tested with respect to incubation periods of one and three hours compared to placebo. The primary endpoint of the study is the absolute change in the number of inflammatory lesions and an improvement in symptoms. To ensure collection of highly consistent data across all participating sites, the study will combine clinical assessments performed by the physicians conducting the study with a cutting-edge, FDA-approved, artificial intelligence analysis platform that will provide a lesion count along with a severity assessment. A total of seven sites are participating in the study.
Ameluz® together with the PDT-lamp series comprising the BF-RhodoLED® and the new model RhodoLED® XL is being marketed by Biofrontera Inc, a US-based affiliate of Biofrontera AG under an exclusive license and supply agreement for the United States.
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