Revolutionary Ameluz-PDT Study Begins: First Patient Dosed in Phase 3 Clinical Trial for Actinic Keratosis Treatment!

Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced a major milestone in its development as the first patient has been successfully dosed in a pivotal Phase 3 clinical study of its Ameluz® and BF-RhodoLED® XL treatments for actinic keratosis. The randomized, double-blind, vehicle-controlled, multicenter study will evaluate the safety and efficacy of the treatments in field-directed treatment of AK on the extremities, neck and trunk. This Phase 3 study is being conducted by Biofrontera Bioscience GmbH, a wholly owned subsidiary of Biofrontera AG.

Biofrontera Inc. is thrilled to announce that the first patient has been dosed in its Phase 3 study, marking a major milestone in the company’s clinical development strategy. Affecting an estimated 58 million Americans, Actinic Keratosis (AK) drives over 13 million treatments a year – and with the potential of Ameluz-PDT to treat AK beyond the face and scalp, the addressable market for this highly effective therapy is ever-expanding.

Ms. Monaco continued, emphasizing Biofrontera Inc.’s commitment to treating AK with Ameluz-PDT: “Our Phase 3 clinical study supports our strategy to expand the label for Ameluz-PDT for use on the extremities, neck and trunk, enabling our leading therapy to help many more people who suffer from AK. Prior clinical trials have already demonstrated impressive results, with up to 91% total clearance on the face and scalp.”

Eleven clinical trial sites across the United States are coming together to take part in a study that will enroll around 165 patients, broken down by body region. All of these sites will use Biofrontera’s newly approved RhodoLED XL, a red-light lamp approved by the FDA for use in Photodynamic Therapy (PDT) in combination with Ameluz® to treat mild-to-moderate actinic keratosis.

About Actinic Keratosis

Actinic keratosis (AK) is a common pre-cancerous skin condition that, if left untreated, can develop into life-threatening skin cancer. Its prevalence is staggering – an estimated 58 million people in the U.S. were affected in 2020, and 13 million AK treatments were performed. AKs usually appear on sun-exposed areas like the face, scalp, arms, and hands. With the right care and attention, this pre-cancerous skin condition can be managed and caught before it turns into something more serious.

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company revolutionizing the treatment of dermatological conditions with its portfolio of pharmaceutical products. The focus is on photodynamic therapy (PDT) and topical antibiotics that are used to treat pre-cancerous skin lesions, known as actinic keratoses, as well as bacterial skin infections like impetigo. With its innovative solutions, Biofrontera is helping to improve the lives of those affected by these skin conditions.

Forward-Looking Statements

This press release may contain forward-looking statements related to the clinical development strategy for Ameluz®, the potential to expand the label of Ameluz®, the addressable market and growing demand for Ameluz®, and ongoing clinical trials conducted in collaboration with our licensing partner. Although we have made our best efforts to base our expectations and projections on current events, the actual results or events could differ materially due to several factors beyond our control, including the current COVID-19 pandemic, changes to the Company’s relationship with its licensors, changes in the practices of healthcare providers, and uncertainties associated with the initiation and conduct of clinical trials. We urge readers to exercise caution when considering these forward-looking statements and to be aware of the potential risks and uncertainties that may arise.

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