Benzinga | Dec 6, 2021 11:43AM EST

Biofrontera AG Announced Eenrollment of First Patient in Phase I Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz

Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F)), an international biopharmaceutical company, is pleased to announce that it has commenced patient enrollment for its phase I safety study to evaluate the safety and tolerability of photodynamic therapy (PDT) for the treatment of mild-to-severe actinic keratosis (AK) on the face and scalp using three tubes of Ameluz(r) together with the newBiofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F)), an international biopharmaceutical company, is pleased to announce that it has commenced patient enrollment for its phase I safety study to evaluate the safety and tolerability of photodynamic therapy (PDT) for the treatment of mild-to-severe actinic keratosis (AK) on the face and scalp using three tubes of Ameluz(r) together with the new BF-RhodoLED(r) XL lamp.

"Our focus remains on expanding the FDA approval of Ameluz(r)," says Hermann Lbbert, CEO of Biofrontera AG. "This study paves the way to allow the U.S. product information for Ameluz(r) to be amended to allow the use of up to three tubes per treatment, as it currently limits the use to one tube of Ameluz(r) per treatment. This is a prerequisite for the alignment of reimbursement modalities compared to the competitor product in the US and thus an increase of the competitiveness of Ameluz(r) in this important market."

The non-randomized, open-label, multicenter study evaluates the safety and tolerability of Ameluz(r) in the treatment of AK located on the face and scalp with PDT together with the new BF-RhodoLED(r) XL lamp. The study includes 100 patients with mild to severe AK. Each patient will receive the content of 3 tubes of Ameluz(r) for a field-directed treatment of AK.

This study comes on the back of a maximal-usage pharmacokinetics (PK) clinical study completed in early 2021. As announced in June, the study results from that PK study were presented to the FDA. In the meeting the FDA requested another safety study focusing on transient adverse events before amending the product information to allow the simultaneous use of up to three tubes per treatment. A total of eight clinical sites are participating in the study.

Ameluz(r) together with the PDT-lamp BF-RhodoLED(r) and its successor model BF-RhodoLED(r) XL is being marketed by Biofrontera Inc, a US-based affiliate of Biofrontera AG under an exclusive license and supply agreement for the United States.