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Biofrontera Inc. Announces Enrollment of First Subject in Phase 2b Clinical Trial Evaluating Ameluz® + BF-RhodoLED® in Moderate-to-Severe Acne
WOBURN, Mass., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of
About this update from Biofrontera Inc.
[{"type":"text","content":"WOBURN, Mass., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the first subject has been enrolled in the Phase 2b study performed by Biofrontera Bioscience GmbH to evaluate the safety and efficacy of Ameluz® in combination with the red-light lamp BF-RhodoLED® for the treatment of moderate-to-severe acne with photodynamic therapy (Ameluz®-PDT). “Ameluz®-PDT has the potential to improve treatment outcomes for millions of Americans with moderate-to-severe acne. This study is an important component of Biofrontera group’s clinical development strategy that aims to expand the FDA-label of our licensed product Ameluz®. The inclusion of additional indications aims at unlocking its full therapeutic and market potential in the US,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc. 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. The efficacy of Ameluz®-PDT will be tested with respect to incubation periods of one and three hours compared to placebo. The composite primary endpoint of the study is the absolute change in the number of inflammatory lesions and an improvement in symptoms. To ensure data consistency across all participating sites, the study will combine clinical assessments performed by the investigators conducting the study with a cutting-edge, FDA-approved, artificial intelligence analysis platform that will provide an automated lesion count along with a severity assessment. A total of seven sites are participating in the study. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit www.biofrontera-us.com. Forward-Looking Statements Certain statements in this press release may constitute \"forward-looking statements\" wit...