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Leverkusen, Germany (pta017/18.01.2023/11:50) - Biofrontera AG (ISIN: DE0006046113), an international biopharmaceutical company, today announced the start of patient recruitment for a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial to evaluate the safety and efficacy of Ameluz® in a field-directed treatment of actinic keratosis (AK) on the extremities, neck and trunk. Biofrontera's new RhodoLED® XL lamp is being used in this clinical trial, a new, larger red-light lamp approved by the US Food and Drug Administration (FDA) for Ameluz®-PDT in the United States in October 2021. This lamp allows illumination of larger areas, enabling simultaneous treatment of widely separated AK lesions.
"Our European Ameluz® label already covers treatment of the extremities, trunk and neck, and we expect to strengthen Ameluz®'s market presence in the US as well with such a label extension. Approximately 45% of US AK patients have actinic keratoses outside the head region [ 1 ] , so it is important to offer a treatment option to these people. With this trial, which is part of a broader US clinical development plan, we aim to increase the potential US market share for Ameluz®-PDT in the long term run", comments Pilar de la Huerta, Chief Financial Officer of Biofrontera AG, on the beginning of the study.
There will be 165 patients enrolled at study sites in the US, each with 4-15 AK lesions in comparable areas on the right and left sides of the extremities and/or trunk/neck. The trial design includes a new illumination profile with the intention to reduce the pain that some patients experience throughout the procedure. Mild to moderate actinic keratoses will be treated with one or, if necessary, two PDT treatments. Patients will have their final examination three months after their last PDT. The clinical study phase will be followed by a follow-up period of twelve months after the last PDT. The primary endpoint of the study is the efficacy measured in the rate of complete healing of all the target lesions three months after the last PDT treatment.
Reference: 1 Yaldiz M. Medicine (Baltimore). 2019;98:e16465.
Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics. The Leverkusen-based company develops and markets innovative products for the treatment, protection and care of the skin. Its key products include Ameluz®, a prescription drug for the treatment of non-melanoma skin cancer and its precursors. Ameluz® has been marketed in the EU since 2012 and in the USA since May 2016. In Europe, the company also markets the Belixos® dermocosmetic series, a specialty care product for damaged skin. Biofrontera is one of a few German pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 and is listed on the Frankfurt Stock Exchange (Prime Standard). www.biofrontera.com
Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "will," "anticipate," "believe," "forecast," "estimate" and "intend," among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, including, but not limited to, the risk that the termination of the ADS Level 1 Program or the deregistration with the SEC may not occur or may be delayed, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.
emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
ISIN(s): DE0006046113 (share)
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