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Biofrontera Inc. Announces First Patient Dosed in Pivotal Phase 3 Clinical Study Evaluating Ameluz(R)-PDT for the Treatment of Actinic Keratosis on the Extremities, Neck and Trunk
WOBURN, MA / ACCESSWIRE / January 9, 2023 / Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company specializing in the commercialization of
About this update from Biofrontera Inc.
[{"type":"text","content":"WOBURN, MA / ACCESSWIRE / January 9, 2023 / Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced that the first patient has been dosed in a Phase 3 randomized, double-blind, vehicle-controlled, multicenter clinical study to evaluate the safety and efficacy of Ameluz® and BF-RhodoLED® XL in the field-directed treatment of actinic keratosis (AK) on the extremities, neck and trunk. This Phase 3 clinical study is being conducted by Biofrontera Bioscience GmbH, a wholly owned subsidiary of Biofrontera AG.\"Having recently kicked off this Phase 3 study with a meeting of clinical trial investigators, dosing the first patient is an important milestone in our clinical development strategy,\" said Erica Monaco, Chief Executive Officer of Biofrontera Inc. \"With AK affecting an estimated 58 million Americans and driving approximately 13 million treatments annually, there is large and growing demand for a highly effective therapy such as Ameluz-PDT to treat AK beyond the face and scalp. We look forward to expanding the addressable market for Ameluz-PDT.\"\"Biofrontera Inc. is at the forefront of treating AK where Ameluz-PDT has demonstrated up to 91% total clearance on the face and scalp in prior clinical trials,\" continued Ms. Monaco. \"This Phase 3 clinical study supports our strategy to expand the label for Ameluz-PDT for use on the extremities, neck and trunk, and ultimately enables our leading therapy to help many more people who suffer from AK.\"Initially 11 clinical trial sites in the U.S. will participate, enrolling approximately 165 patients stratified by body region. This study utilizes Biofrontera's new RhodoLED XL, a red-light lamp approved by the U.S. Food and Drug Administration (FDA) for use in PDT in combination with Ameluz® (Ameluz - PDT) for the treatment of mild-to-moderate actinic keratosis.About Actinic KeratosisActinic keratosis (AK) is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. According to the Skin Cancer Foundation, in the U.S. AK affected approximately 58 million people in 2020 and an estimated ...