Biofrontera Inc., a biopharmaceutical company specializing in dermatological products, has reported positive results from its Phase 1 safety study on photodynamic therapy (PDT) for the treatment of actinic keratosis (AK). The study evaluated the safety and tolerability of using three entire tubes of BF-200 ALA (Ameluz®) in combination with the RhodoLED® XL lamp.
The study involved 100 patients treated at nine participating clinical centers. The incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information based on studies with one tube. The treatment was generally well tolerated, and all TEAEs were transient, resolving within one to four days after PDT. No Serious Adverse Events (SAEs) or other clinically relevant AEs were reported, and no subjects discontinued the study due to a TEAE.
Based on these positive results, Biofrontera Inc. plans to present the findings to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year. The company aims to have the FDA amend the product information to allow the use of up to three tubes of Ameluz® per treatment. Currently, the product information limits treatment to one tube at a time.
Hermann Luebbert, Chairman and CEO of Biofrontera Inc., highlighted the benefits of treating AK with three tubes of Ameluz®, including the ability to treat a wider affected area and potentially requiring fewer office visits. He expects the FDA to waive the restriction and broaden the Ameluz® label based on the positive results of this study and a previous pharmacokinetics study.
In addition to the Phase 1 safety study, Biofrontera Inc. has recently completed patient enrollment in a Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED® lamp for the treatment of basal cell carcinoma. The study is treating 187 patients, and the last patient’s final assessment is expected in the first quarter of 2024.
Actinic keratosis is a common pre-cancerous skin lesion caused by chronic sun exposure. If left untreated, it can develop into squamous cell carcinoma, a life-threatening form of skin cancer. In the United States, approximately 58 million people were affected by AK in 2020, and an estimated 13 million AK treatments were performed.
Biofrontera Inc. is focused on commercializing dermatologic products, particularly in the areas of photodynamic therapy and topical antibiotics. The company’s licensed products are used for the treatment of actinic keratosis and impetigo, a bacterial skin infection.
