Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) completed the final patient visit in a Phase 1 pharmacokinetic study of Ameluz gel 10% for treatment of mild-to-moderate actinic keratoses on the neck, trunk and extremities; the last visit occurred on 24 November 2025.

Under maximal-use conditions three tubes were applied to ~240 cm2; 17 patients received one PDT treatment and blood samples were collected over 10 hours to assess systemic ALA and PpIX exposure. Data plus a completed Phase 3 will form the basis for a planned sNDA submission in Summer 2026 to expand Ameluz labeling to peripheral body areas.

Positive

• Phase 1 last patient visit on 24 November 2025
• Study used maximal-use conditions: 3 tubes on ~240 cm2
• 17 patients dosed with PK sampling over 10 hours
• Data to support planned sNDA submission Summer 2026

Negative

• sNDA submission is conditional on positive outcomes from this trial and Phase 3
• Phase 1 cohort size was 17 patients, a limited sample for systemic PK assessment

Insights

Clinical Regulatory Strategist

Completion of a Phase 1 maximal‑use PK study enables a planned Summer 2026 sNDA submission but provides no efficacy or safety readouts yet.

Biofrontera completed the final patient visit on 24 November 2025 for a 17‑patient open‑label Phase 1 pharmacokinetic study of Ameluz®, applying three tubes over ~240 cm2 and sampling blood for ALA and PpIX over 10 hours under maximal‑use conditions. This step supplies the systemic exposure data regulators typically require when expanding a topical drug label to larger body areas, and it pairs with the recently completed Phase 3 trial as the intended basis for a supplemental NDA.

Key dependencies and risks include the actual PK results (not disclosed here), the Phase 3 outcomes, and FDA review interpretation of systemic exposure versus safety; none of these outcomes are stated. Watch for the PK dataset, a formal safety summary, and the sNDA filing timing toward Summer 2026, as those items will determine regulatory leverage and near‑term impact on labeling and market access.

• Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz^® over treatment area of 240 cm²
• Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz^® on all non-face and scalp areas

WOBURN, Mass., Dec. 04, 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 completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz^® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas). The last patient visit took place on 24 November 2025.

Data from this study, together with results from Biofrontera’s recently completed Phase 3 clinical trial, will form the basis of a planned supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the Ameluz^® label to include the treatment of AKs on all peripheral body areas. Actinic keratoses commonly occur on sun-exposed areas across the body and may progress to squamous cell carcinoma if left untreated. Expanding Ameluz^®’s current FDA approval for use beyond the face and scalp would address a critical unmet need in dermatology.

This open-label Phase 1 study assessed the PK profile of 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during Ameluz^®-PDT of the upper extremities, neck or trunk using the BF-RhodoLED^® XL lamp. Under maximal use conditions, three tubes of Ameluz^® were applied to a treatment area of approximately 240 cm². Seventeen patients received one PDT treatment and blood samples were taken over the 10 hours following the application of Ameluz^® to assess the systemic exposure to ALA and PpIX.

“We are delighted to reach this important clinical milestone” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “Completion of this Phase 1 study is a key step toward expanding the use of Ameluz^® to treat Actinic Keratoses on the extremities, neck and trunk. If approved this label extension would not only provide meaningful benefits for patients but would be an immense step forward toward our vision to become market leaders in the field of PDT in dermatology.”

Dr. Ted Lain, board-certified dermatologist, Chief Medical Officer of Sanova Dermatology, Executive Director for the Austin Institute for Clinical Research (AICR) and a key contributor to the Phase 1 study stated “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 I look forward to potentially having this as an approved option for my patients.”

Pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the Summer 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.¹

1. 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 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 Biofrontera's commercial opportunities and the commercial success of its 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; the ability of the Company’s manufacturing partners to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether any global disruptions in supply chains will impact the Company’s ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s 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. 

Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

FAQ

What did Biofrontera (BFRI) announce on December 4, 2025 about Ameluz?

Biofrontera announced completion of the final patient visit in a Phase 1 PK study for Ameluz on peripheral body areas, with the last visit on 24 Nov 2025.

How many patients were enrolled in Biofrontera's Phase 1 Ameluz PK study (BFRI)?

Seventeen patients received one PDT treatment and had blood samples taken over 10 hours.

What were the dosing and maximal-use conditions in the Ameluz Phase 1 study (BFRI)?

Under maximal-use conditions three tubes of Ameluz were applied to a treatment area of approximately 240 cm2.

When does Biofrontera plan to submit the sNDA to the FDA for Ameluz (BFRI)?

The company plans to submit a supplemental New Drug Application to the FDA in Summer 2026, pending positive study outcomes.

What measurements did the Phase 1 Ameluz study collect for Biofrontera?

The study assessed systemic exposure to ALA and its metabolite PpIX via blood sampling over a 10-hour post-application period.