Biofrontera Inc. Enrolls First Subject in Phase 1 Safety Study Evaluating Photodynamic Therapy With Three Tubes of Ameluz
Biofrontera Inc. recently announced the first subject has been enrolled in a Phase 1 study to evaluate the safety and tolerability of photodynamic therapy (PDT) for the treatment of actinic keratosis (AK) using three tubes of Ameluz together with the company’s BF-RhodoLED XL lamp. This open-label study is being conducted at eight sites and will enroll 100 subjects with mild-to-severe AK on the face and scalp.
“Today’s news marks an important step in our clinical program for optimizing the positioning of our flagship product Ameluz,” said Erica Monaco, Chief Executive Officer of Biofrontera Inc. “The use of three tubes of Ameluz enables treatment of larger surface areas such as for mild-to-severe AK on the face and scalp. Success with this study could significantly improve the competitiveness of Ameluz in the US and advance Biofrontera’s goal of gaining market share for PDT as standard of care for treatment of AK.”
The Phase 1 study follows a maximal-usage pharmacokinetics (PK) clinical study that was completed in early 2021. As announced in June, results from that PK study were presented to the US FDA. The FDA subsequently requested another safety study focusing on transient adverse events before amending the product information, which currently limits use to one tube of Ameluz per treatment.
Biofrontera Inc. is a US-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions. With a focus on the fields of photodynamic therapy (PDT) and topical antibiotics, Biofrontera currently commercializes the FDA-approved flagship drug Ameluz in the US. When used in combination with PDT and Biofrontera’s BF-RhodoLED lamp, Ameluz-PDT is indicated for the treatment of actinic keratoses (AK), one of the most common precancerous skin conditions. Biofrontera also commercializes Xepi, an FDA-approved drug for the treatment of impetigo. In collaboration with dermatologists, Biofrontera is fully committed to advancing treatment options and patient care. For more information, visit www.biofrontera-us.com.
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