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Biofrontera Inc. Announces Positive Results from Phase 1 Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz(R)
WOBURN, MA / ACCESSWIRE / August 28, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization
About this update from Biofrontera Inc.
[{"type":"text","content":"WOBURN, MA / ACCESSWIRE / August 28, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the \"Company\"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces positive topline results from its non-randomized, open-label, multicenter Phase 1 study evaluating the safety and tolerability of 3 entire tubes of BF-200 ALA (Ameluz®) in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT) using the RhodoLED® XL lamp. Of the 100 patients treated in 9 participating clinical centers, the incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information (US PI) that are based on studies with 1 tube. The treatment was generally well tolerated and TEAEs were as expected due to the therapeutic principle of photodynamic therapy. All TEAEs were transient. In most cases, they resolved within 1 to 4 days after PDT, but occasionally persisted for 1 to 2 weeks or in a few cases even longer, similar to the TEAEs observed after single-tube PDT. No Serious Adverse Events (SAEs), deaths or other clinically relevant AEs were reported during the study and no subject discontinued the study due to a TEAE.With results demonstrating no additional safety or tolerability issues with 3 tubes, Biofrontera Inc. intends to present these findings to the U.S. Food and Drug Administration (FDA) during the fourth quarter of this year. This Phase 1 study, conducted by Biofrontera Bioscience GmbH, follows a maximal-usage pharmacokinetics study presented to the FDA in 2021, upon which the FDA requested another safety study focusing on transient side effects before amending the product information, which currently limits use to one tube of Ameluz® per treatment.\"The positive results demonstrated there were no additional safety risks in treatment of AK with three tubes of Ameluz compared to one tube. There are benefits of treatment with 3 tubes for both physicians and patients because of the ability to treat a wider affected area while potentially requiring fewer office visits. With the results of this study and the previously reported pharmacokinetics study, we expect the FDA to waive the restriction limiting treatment to 1 tube at a time, broadening the Ameluz® label for using up to 3 tubes. Ameluz® is the only PDT drug FDA approve...