Biofrontera announced final patient enrollment for a Phase 3 trial on Ameluz® for actinic keratoses treatment.
Quiver AI Summary
Biofrontera Inc. has completed enrollment for its Phase 3 clinical trial of Ameluz® photodynamic therapy (PDT), aiming to treat mild to moderate actinic keratoses (AKs) on the neck, trunk, and extremities. This multicenter trial compares Ameluz® with a vehicle gel, assessing the safety and efficacy of PDT on up to 240 cm² of treated area. The treatment phase is expected to conclude by Q3 2025, with a follow-up lasting about a year after the last treatment. Biofrontera plans to submit a supplemental New Drug Application to the FDA in late 2026 based on the trial results. Actinic keratosis is a common skin condition that can develop into squamous cell carcinoma if untreated, affecting millions in the U.S. Biofrontera specializes in dermatological treatments, particularly focusing on PDT.
Potential Positives
- Completion of patient enrollment in a significant Phase 3 clinical trial for Ameluz® signifies progress in the development of treatment options for actinic keratoses (AKs) on the extremities, neck, and trunk.
- The trial aims to address an unmet need in dermatology by expanding treatment indications, potentially increasing market opportunities for Biofrontera.
- Positive trial results may lead to a supplemental New Drug Application (sNDA) submission to the FDA, enhancing regulatory approval prospects for Ameluz®.
- Expert endorsement from Principal Investigator highlights the promising nature of Ameluz® PDT for treating lesions beyond the face and scalp, which could enhance the company's reputation in the dermatological treatment landscape.
Potential Negatives
- The press release highlights a significant timeline for the completion of the treatment phase in Q3 2025, which indicates that positive results are not immediate and further delays could occur in the regulatory submission process.
- It mentions multiple potential risks and uncertainties, such as reliance on licensors and the impact of global supply chain disruptions, which could affect the company's ability to deliver its products.
- The use of “forward-looking statements” could raise concerns among investors about the unpredictability of outcomes related to clinical trials and the future market success of Ameluz®.
FAQ
What is the purpose of the Phase 3 study for Ameluz®?
The study evaluates Ameluz® for treating mild to moderate actinic keratoses on the extremities, neck, and trunk.
What does the protocol for the study involve?
The protocol involves one or two PDT treatments using 1-3 tubes of Ameluz® or vehicle gel over up to 240 cm².
When is the treatment phase of the study expected to be completed?
The treatment phase is expected to be complete by Q3 2025.
How many patients were enrolled in the trial?
A total of 172 patients were enrolled in the clinical trial for the study.
What is Biofrontera's plan after the trial?
If results are positive, Biofrontera plans to submit a supplemental New Drug Application to the FDA in late 2026.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
First US Phase 3 study of Photodynamic Therapy (PDT) to include neck, trunk and extremities
Protocol involves one or two PDT treatments using 1-3 tubes of Ameluz
®
or vehicle gel over a surface area of up to 240 cm
2
Treatment phase expected to be complete by Q3 2025
WOBURN, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”)
, a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz
®
(aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk. Actinic keratosis is a common skin condition found on sun-exposed areas of the body, and if left untreated, may progress to squamous cell carcinoma. Expanding field treatment options for AKs beyond the face and scalp would address a critical unmet need in dermatology.
This trial is a multicenter, randomized, double-blind study comparing Ameluz
®
with vehicle in the field-directed treatment of actinic keratoses (AK) located on the extremities, neck and trunk with PDT using a RhodoLED lamp (BF-RhodoLED
®
XL or BF-RhodoLED
®
). It is designed to assess the safety and efficacy of Ameluz
®
PDT following the application of 1-3 tubes of product over a surface area (continuous or in patches) of approximately 80, 160 or 240cm
2
. Patients receive one PDT treatment with either Ameluz
®
or vehicle gel, and a second one at 12 weeks if at least one AK lesion remains. They are then followed up for approximately one year after the last PDT treatment. The study enrolled 172 patients who received either Ameluz
®
or vehicle gel in a ratio of 4:1.
“We are thrilled to reach this pivotal stage in our clinical program,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “The successful enrollment of our last patient brings us one step closer to potentially offering an effective treatment option for patients with actinic keratoses on the extremities, neck and trunk. It marks a significant step in expanding the indications for Ameluz
®
and further demonstrates our commitment to the development of PDT.”
Dr. Nathalie Zeitouni, Mohs surgeon and principal investigator at Medical Dermatology Specialists, Professor of Dermatology at the University of Arizona COM Phoenix, discussed the potential impact of the study. “Ameluz
®
PDT has already proven to be a valuable option for the treatment of AKs on the face and scalp. We see many patients who have these lesions on other areas of the body, and the possibility of expanding the use of Ameluz
®
to treat those areas is promising for both physicians and for our patients. I look forward to seeing the results of this study."
With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026.
About Actinic 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. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.
3
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz
®
with the RhodoLED
®
lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit
www.biofrontera-us.com
and follow Biofrontera on
LinkedIn
and
X
.
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. These statements include, but are not limited to, statements relating to the clinical development strategy for Ameluz
®
, ongoing clinical trials and the future impact of such trials on the market for Ameluz
®
, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. 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, include, but are not limited to: the impact of any extraordinary external events; 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
®
and/or RhodoLED
®
XL 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
®
and/or RhodoLED
®
XL is consistent with the Company’s expectations; 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 Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at
www.sec.gov
.
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.
Contact:
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com
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