Benzinga | Dec 6, 2021 11:36AM EST

Biofrontera Earlier Announced Enrollment Of 1st Subject In Phase 1 Safety Study Evaluating Photodynamic Therapy With 3 Tubes Of Ameluz

Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that 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(r) together with the company's BF-RhodoLED(r) 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(r)," commented Erica Monaco, Chief Executive Officer of Biofrontera Inc. "The use of three tubes of Ameluz(r) 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(r) in the U.S. 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 U.S. Food and Drug Administration (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(r) per treatment.