Biofrontera to Launch Phase 3 Clinical Study Evaluating Ameluz®-PDT for the Treatment of Actinic Keratosis on the Extremities, Neck and Trunk

WOBURN, Mass., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of a randomized, double-blind, vehicle-controlled, multicenter Phase 3 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. The study is being managed by Biofrontera Bioscience GmbH.

This past weekend Biofrontera held an Investigator Meeting to train clinical investigators on the protocol for this photodynamic therapy (PDT) study and prepare for site initiation. Initially 11 clinical trial sites in the U.S. will participate, enrolling approximately 165 patients stratified by body region. This study will utilize 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. This lamp allows for the illumination of a larger surface area, thereby enabling simultaneous treatment of AK lesions that are distant from one another.

“This Phase 3 clinical study supports our strategy to gain market share by expanding the label for Ameluz^®-PDT beyond the treatment of AK on the face and scalp. Additionally, by employing the larger RhodoLED^® XL lamp investigators can target more lesions and reinforce the lamp’s utility ahead of commercial launch,” said Erica Monaco, Chief Executive Officer of Biofrontera Inc.

Patients enrolled in this study will have 4-15 mild-to-moderate AK lesions in the treatment field. Each will be treated once with Ameluz^®-PDT and upon a three-month evaluation, will be treated a second time if any lesions remain. Investigators will continue to follow patients for 12 months after their most recent treatment to monitor for any recurrences or new lesions, as well as for any adverse events. The primary endpoint is total clearance of all lesions three months after the most recent treatment. Secondary endpoints are total clearance of all lesions three months after the last treatment by body region, percentage of all lesions cleared overall and percentage cleared by body region and severity.

Ameluz^® and the BF-RhodoLED^® lamps, through Biofrontera Inc.’s license and supply agreement with Biofrontera AG, are also undergoing clinical testing in three additional indications:

1. A Phase 3 clinical study in the U.S. evaluating Ameluz^®-PDT utilizing the BF-RhodoLED^® lamp for the treatment of superficial basal cell carcinoma.
   
   
2. A multicenter, randomized, double-blind Phase 2 clinical study evaluating the efficacy of Ameluz^®-PDT for the treatment of moderate-to-severe acne.
   
   
3. An open-label, multicenter Phase 1 clinical study evaluating the safety and tolerability of Ameluz-PDT for the treatment of AK located on the face and scalp utilizing the BF-RhodoLED^® XL lamp and three tubes of Ameluz^®.
   
   

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit .

Forward-Looking Statements

Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Biofrontera Inc.’s (the “Company”) revenue guidance for 2022, the Company’s relationship with Biofrontera AG (including beneficial ownership of Biofrontera AG’s shares and future collaboration between the Company and Biofrontera AG), business and marketing strategy, hiring strategy, development of medical affairs initiatives, growth of the Company’s profile, future operations and business, increased patent protection for our licensed products, potential to expand the label of Ameluz^® , market presence and position of Ameluz^® and ongoing clinical trials conducted by our licensing partners and the future impact of such trials on the market for Ameluz^®. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, including, but not limited to, the impact of extraordinary external events, such as the current COVID-19 pandemic; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz^® in combination with BF-RhodoLED^® in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz^® in combination with BF-RhodoLED^® is consistent with the Company’s expectations; the Company’s ability to complete the transition to a public company; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing and other factors that may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Contacts

Biofrontera Inc.

Anke zur Mühlen

LHA Investor Relations

Tirth T. Patel

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