Biofrontera completes one-year follow-up in Phase 3 sBCC study; FDA submission expected Q3 2025 after significant results.
Quiver AI Summary
Biofrontera Inc. announced that the last patient in its Phase 3 study, ALA-BCC-CT013, of Ameluz and RhodoLED PDT for treating superficial basal cell carcinoma (sBCC) completed their one-year follow-up in December 2024. The study involved 187 patients and achieved highly statistically significant results for all primary and secondary endpoints, with data expected to be included in an FDA submission in Q3 2025. The company is working to follow sBCC lesions for a total of five years, as mandated by the FDA for dermatology product submissions. Biofrontera's CEO, Dr. Hermann Luebbert, expressed optimism about the results and the potential to expand treatment options for sBCC. The press release emphasizes the significance of this study given the prevalence of basal cell carcinoma in the U.S., which sees over 3 million cases annually.
Potential Positives
- Completion of the 1-year follow-up in the Phase 3 study of Ameluz and RhodoLED PDT for treating superficial BCC is a critical milestone, enhancing the credibility of Biofrontera's research efforts.
- The highly statistically significant results (p 0.0001) achieved for all primary and secondary endpoints suggest a strong efficacy of the treatment, bolstering the company's position in the dermatological market.
- Data from the study will be included in the FDA submission expected in Q3 2025, indicating progress towards potential regulatory approval for a treatment option addressing a significant medical need.
- The commitment to long-term follow-up for patients aligns with FDA requirements and highlights the company's dedication to patient safety and thorough evaluation of treatment outcomes.
Potential Negatives
- The press release includes a disclaimer about forward-looking statements, indicating potential risks and uncertainties that could significantly impact future outcomes for the company and its products.
- Long-term follow-up studies are mandated by the FDA, which could suggest potential concerns over the short-term efficacy or safety of the treatment being studied.
- The statement highlights the need for ongoing clinical trials and does not guarantee success in obtaining regulatory approval or achieving commercial success for the drug, creating uncertainty about the company's future prospects.
FAQ
What is the ALA-BCC-CT013 study about?
The ALA-BCC-CT013 study evaluates the safety and efficacy of Ameluz and RhodoLED PDT for treating superficial BCC.
When will the FDA submission happen?
The FDA submission, which includes one-year follow-up data, is expected in the third quarter of 2025.
What are the results of the study?
The study reported highly statistically significant results for primary and secondary endpoints with p 0.0001 in October 2024.
What is superficial BCC (sBCC)?
Superficial BCC is a common and treatable form of skin cancer that arises from basal cells in the epidermis.
How does Biofrontera plan to expand its product use?
Biofrontera aims to extend the use of Ameluz for non-melanoma skin cancers and improve patient care through partnerships.
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
Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024.
Data from follow-up will be included in FDA submission, expected in Q3 2025.
Biofrontera announced highly statistically significant results for all primary and secondary endpoints (p <0.0001) in October 2024.
BCC, of which sBCC is a subgroup, is the most common skin cancer in the US with more than 3 million cases each year
1
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WOBURN, Mass., Jan. 08, 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 that a key milestone in its Phase 3 study of the use of Ameluz and RhodoLED PDT in the treatment of sBCC (ALA-BCC-CT013) was met with the last patient completing the 1 year follow-up visit in December of 2024.
The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz
®
-PDT or placebo-PDT) 1-2 weeks apart. Lesions that were not completely resolved after 3 months were retreated. The FDA has advised Biofrontera to submit the sNDA with one-year follow-up data. While 1-year data will support the FDA submission, the superficial BCC lesions will in total be followed up for five years.
Long-term follow-up studies are often required by the FDA for dermatology product submissions, in particular for skin cancers, and they are important in trials enrolling sBCC patients due to the risk of local recurrence, or subsequent additional skin cancer development.
“We were delighted with the highly statistically significant results for the primary and secondary endpoints that we communicated last year”, stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc.
“The completion of the 1-year follow-up is a crucial milestone in our path to an FDA submission in 2025 and potentially expanding our label to the treatment of a cutaneous malignancy. It demonstrates our continued investment in PDT and supports our vision of partnering with the dermatology community to improve patient care” he concluded.
“We routinely use PDT in our institution for the treatment of actinic keratoses” commented Dr Shane Chapman, Chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth, and an investigator for ALA-BCC-CT013. “We were impressed with the results of the 12-week data and I look forward to being able to offer Ameluz-PDT as a treatment option for my patients with sBCC”.
About
Basal
Cell
Carcinoma
BCC is the most common form of skin cancer and the most frequently occurring form of all cancers. In the U.S. alone, an estimated 3.6 million cases are diagnosed each year, a subset of which is superficial basal cell carcinoma. BCCs arise from abnormal, uncontrolled growth of basal cells at the bottom of the epidermis. They rarely spread beyond the original tumor site but, if untreated, can become locally invasive, grow wide and deep into the skin, and destroy skin, tissue and bone.
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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
Twitter
.
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
®
, 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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