Biofrontera Inc. Announces Database Lock Of Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)

Rhea-AI Summary

Biofrontera Inc. (Nasdaq: BFRI) has announced the database lock for its Phase 3 study ALA-BCC-CT013, evaluating Ameluz®-Photodynamic Therapy (PDT) for treating superficial Basal Cell Carcinoma (sBCC). This marks the end of data collection for the treatment phase, with analysis now underway. The study, involving 186 patients, is the first Phase 3 PDT trial for sBCC in the United States.

Key points:

• Double-blind, randomized, placebo-controlled multi-center study
• Primary endpoint: complete clinical and histological clearance of target BCC lesion
• Interim results expected November 2024
• FDA submission targeted for Q1 2025, including 1-year follow-up data

If approved, this would expand Biofrontera's label from premalignant applications to treating cutaneous malignancy, advancing their goal of becoming market leaders in PDT.

Positive

• First Phase 3 PDT study for sBCC treatment in the United States
• Database lock achieved, signaling completion of data collection phase
• Potential label expansion from premalignant to malignant skin cancer treatment
• Large target market with over 3 million BCC cases annually in the US

Negative

• Final results and FDA approval still pending
• Submission to FDA not expected until Q1 2025
• Efficacy and safety data not yet available

Insights

Medical Research Analyst

The database lock for Biofrontera's Phase 3 study of Ameluz®-PDT in treating superficial basal cell carcinoma (sBCC) is a significant milestone. This study is important as it's the first Phase 3 PDT trial for sBCC in the U.S., with rigorous dual endpoints requiring both clinical and cytological clearance. The trial's design, involving 186 patients and a double-blind, randomized, placebo-controlled approach, adds credibility to the potential results.

Key points to consider:

• BCC is the most common skin cancer in the U.S., with over 3 million cases annually, indicating a large potential market.
• The primary endpoint composite of complete clinical and histological clearance at 12 weeks post-treatment is a stringent measure of efficacy.
• FDA submission is targeted for Q1 2025, including 1-year follow-up data, which could lead to potential approval and market entry in late 2025 or 2026.
• If approved, this would expand Ameluz®'s label from premalignant to malignant skin conditions, potentially increasing its market share and revenue potential significantly.

While the interim results expected in November 2024 will provide initial insights, investors should remain cautious until full data are available and FDA review is complete.

• First Phase 3 PDT study in patients with sBCC in the United States.
• Rigorous dual endpoints requiring complete clinical and cytological clearance of malignant lesions.
• Data now being analyzed, interim results expected November 2024.
• BCC is the most common skin cancer in the US with more than 3 million cases each year¹.

WOBURN, Mass., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), announced today that the database for the treatment phase of study ALA-BCC-CT013 has been locked.

The database lock is an important milestone in the lifecycle of a clinical trial, marking the end of data collection and the point at which no further changes can be made to the trial database. The clinical data are now ready for final analysis.

This Phase 3 trial is to evaluate the safety and efficacy of Ameluz^®-PDT in combination with the BF-RhodoLED^® lamp for the treatment of sBCC. It is a double-blind, randomized, placebo-controlled multi-center study involving 186 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, repeated after three months if required. The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were evaluated.

In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for Q1 2025.

“If this indication is granted by the FDA this would expand our label from premalignant application for Actinic Keratoses to the treatment of cutaneous malignancy. It would be the next stage in our continued development of PDT and part of our vision to become the market leaders in this field” stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc.

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.²
1. https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
2. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/

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 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

FAQ

What is the purpose of Biofrontera's (BFRI) Phase 3 study for Ameluz®-PDT?

The Phase 3 study (ALA-BCC-CT013) aims to evaluate the safety and efficacy of Ameluz®-PDT in combination with the BF-RhodoLED® lamp for treating superficial Basal Cell Carcinoma (sBCC).

When are the interim results of Biofrontera's (BFRI) Phase 3 sBCC study expected?

Interim results of Biofrontera's Phase 3 study for Ameluz®-PDT in treating sBCC are expected in November 2024.

What is the primary endpoint of Biofrontera's (BFRI) Phase 3 sBCC study?

The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle.

When does Biofrontera (BFRI) plan to submit the sBCC study results to the FDA?

Biofrontera plans to submit the sBCC study results, including 1-year follow-up data, to the FDA in Q1 2025.