Biofrontera Files Investigational NDA for Phase 3 Trial of Ameluz for BCC


Biofrontera AG has filed an investigational new drug (IND) application with the FDA for its proposed Phase 3 study protocol to evaluate Ameluz® photodynamic therapy (PDT) for the treatment of superficial basal cell carcinoma.
The IND filing is in accordance with the advice provided by FDA during a formal Type C meeting in July 2017, in which the requirements for the approval of Ameluz for sBCC based on a single additional phase III trial to be conducted in the US were discussed. The study will compare Ameluz PDT to placebo PDT. The results exhibited in the European BCC trial demonstrating Ameluz’s high efficacy (approximately 95% of superficial BCCs were clinically cleared) and low recurrence rates (5.4% after 12 months) were taken into account for the design of the new trial.
“BCCs are the most common infiltrating tumors in humans, accounting for approximately 50-80% of all invasive skin cancers. Ameluz offers a potential alternative to surgical removal, which can result in clearly visible scarring," commented Prof. Dr. Hermann Lübbert, CEO of Biofrontera. “With the submission of our IND application complete, we look forward to initiating the Phase 3 trial to potentially expand the label of Ameluz® PDT to superficial BCC in the US, which would allow dermatologists and their patients to benefit from innovative and non-invasive treatment options.”
Ameluz is currently approved and available in the EU for the photodynamic therapy of superficial and nodular BCC. It is also approved in both the US and EU for lesion-directed and field-directed PDT of actinic keratosis, a skin cancer precursor.

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