Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk
Biofrontera (Nasdaq: BFRI) has completed patient enrollment in its Phase 3 clinical trial evaluating Ameluz® for treating mild to moderate actinic keratoses (AKs) on extremities, neck and trunk. The study enrolled 172 patients in a 4:1 ratio receiving either Ameluz® or vehicle gel.
This multicenter, randomized, double-blind study will assess the safety and efficacy of Ameluz® PDT using 1-3 tubes over surface areas of 80-240cm². Patients receive one PDT treatment, with a second treatment at 12 weeks if AK lesions remain, followed by a one-year monitoring period.
The treatment phase is expected to complete by September 2025, with follow-up concluding in Q2 2026. Upon positive outcomes, Biofrontera plans to submit a supplemental New Drug Application to the FDA in second half of 2026.
Biofrontera (Nasdaq: BFRI) ha completato l'arruolamento dei pazienti nel suo studio clinico di Fase 3 che valuta Ameluz® per il trattamento delle cheratosi attiniche (AK) da lievi a moderate su estremità, collo e tronco. Lo studio ha arruolato 172 pazienti in un rapporto di 4:1, ricevendo o Ameluz® o gel veicolo.
Questo studio multicentrico, randomizzato e in doppio cieco valuterà la sicurezza e l'efficacia della PDT con Ameluz® utilizzando da 1 a 3 tubi su aree superficiali di 80-240 cm². I pazienti ricevono un trattamento PDT, con un secondo trattamento a 12 settimane se le lesioni AK persistono, seguito da un periodo di monitoraggio di un anno.
Si prevede che la fase di trattamento si concluda entro settembre 2025, con il follow-up che terminerà nel secondo trimestre del 2026. In caso di esiti positivi, Biofrontera prevede di presentare una domanda di approvazione supplementare per un nuovo farmaco alla FDA nella seconda metà del 2026.
Biofrontera (Nasdaq: BFRI) ha completado el reclutamiento de pacientes en su ensayo clínico de Fase 3 que evalúa Ameluz® para el tratamiento de queratosis actínicas (AK) de leve a moderada en extremidades, cuello y tronco. El estudio reclutó a 172 pacientes en una proporción de 4:1 que recibieron Ameluz® o gel vehículo.
Este estudio multicéntrico, aleatorizado y doble ciego evaluará la seguridad y la eficacia de la PDT con Ameluz® utilizando de 1 a 3 tubos en áreas superficiales de 80-240 cm². Los pacientes reciben un tratamiento de PDT, con un segundo tratamiento a las 12 semanas si las lesiones de AK persisten, seguido de un período de monitoreo de un año.
Se espera que la fase de tratamiento se complete para septiembre de 2025, con el seguimiento concluyendo en el segundo trimestre de 2026. Si los resultados son positivos, Biofrontera planea presentar una solicitud de nuevo medicamento suplementario a la FDA en la segunda mitad de 2026.
Biofrontera (Nasdaq: BFRI)는 사지, 목, 몸통의 경증에서 중등증의 광선각화증(AK) 치료를 위한 Ameluz®의 3상 임상 시험에서 환자 모집을 완료했습니다. 이 연구는 172명의 환자를 4:1 비율로 모집하여 Ameluz® 또는 차량 젤을 받았습니다.
이 다기관, 무작위, 이중 맹검 연구는 80-240cm²의 표면적에 대해 1-3개의 튜브를 사용한 Ameluz® PDT의 안전성과 효능을 평가할 것입니다. 환자는 한 번의 PDT 치료를 받고, AK 병변이 남아 있을 경우 12주 후에 두 번째 치료를 받으며, 이어서 1년간 모니터링 기간이 있습니다.
치료 단계는 2025년 9월까지 완료될 것으로 예상되며, 후속 조치는 2026년 2분기에 종료됩니다. 긍정적인 결과가 나올 경우 Biofrontera는 2026년 하반기에 FDA에 보충 신약 신청서를 제출할 계획입니다.
Biofrontera (Nasdaq: BFRI) a terminé le recrutement des patients dans son essai clinique de Phase 3 évaluant Ameluz® pour le traitement des kératoses actiniques (AK) légères à modérées sur les extrémités, le cou et le tronc. L'étude a recruté 172 patients dans un rapport de 4:1 recevant soit Ameluz®, soit un gel véhicule.
Cette étude multicentrique, randomisée et en double aveugle évaluera la sécurité et l'efficacité de la PDT avec Ameluz® utilisant de 1 à 3 tubes sur des surfaces allant de 80 à 240 cm². Les patients reçoivent un traitement PDT, avec un second traitement à 12 semaines si les lésions AK persistent, suivi d'une période de surveillance d'un an.
La phase de traitement devrait se terminer d'ici septembre 2025, avec un suivi qui se conclura au deuxième trimestre de 2026. En cas de résultats positifs, Biofrontera prévoit de soumettre une demande d'autorisation de médicament complémentaire à la FDA dans la seconde moitié de 2026.
Biofrontera (Nasdaq: BFRI) hat die Patientenrekrutierung in seiner Phase-3-Studie abgeschlossen, die Ameluz® zur Behandlung von milden bis moderaten aktinischen Keratosen (AK) an Extremitäten, Hals und Rumpf bewertet. Die Studie rekrutierte 172 Patienten in einem Verhältnis von 4:1, die entweder Ameluz® oder ein Vehikelgel erhielten.
Diese multizentrische, randomisierte, doppelblinde Studie wird die Sicherheit und Wirksamkeit von Ameluz® PDT unter Verwendung von 1-3 Tuben über Oberflächenbereichen von 80-240 cm² bewerten. Die Patienten erhalten eine PDT-Behandlung, mit einer zweiten Behandlung nach 12 Wochen, falls AK-Läsionen bestehen bleiben, gefolgt von einer einjährigen Überwachungsphase.
Die Behandlungsphase soll bis September 2025 abgeschlossen sein, mit einem Follow-up, das im 2. Quartal 2026 endet. Bei positiven Ergebnissen plant Biofrontera, in der zweiten Hälfte von 2026 einen ergänzenden Antrag auf Zulassung eines neuen Arzneimittels bei der FDA einzureichen.
- First US Phase 3 PDT study expanding treatment areas beyond face/scalp
- Large-scale trial with 172 patients enrolled
- Study allows treatment of extensive areas up to 240 cm²
- Results and potential FDA approval not expected until late 2026
- Requires up to 3 tubes of product per treatment area
- May need second treatment if lesions persist after 12 weeks
Insights
Biofrontera's announcement of completed enrollment in their Phase 3 trial for Ameluz® represents a significant milestone in their product expansion strategy. This trial could substantially increase the addressable market for their flagship product by extending treatment capabilities beyond the currently approved face and scalp regions to include extremities, neck, and trunk areas.
The study design is particularly noteworthy with its 4:1 randomization ratio favoring the treatment arm, suggesting confidence in efficacy while still maintaining scientific validity. With 172 patients enrolled, the trial has reached adequate power for statistical significance in this indication.
From a commercial perspective, expanding Ameluz® indications would address an important market opportunity, as actinic keratoses frequently occur on body areas beyond the face and scalp. This potential label expansion aligns with Biofrontera's focus on maximizing the commercial potential of their existing assets rather than pursuing costly new drug development.
The clearly defined timeline—treatment phase completion by Q3 2025, follow-up by Q2 2026, and potential FDA submission in H2 2026—provides investors with concrete milestones to monitor. However, investors should note that revenue impact from this expanded indication would not materialize until at least 2027, assuming trial success and regulatory approval.
This Phase 3 trial represents an important advancement in the field of dermatological oncology. Actinic keratoses (AKs) are precancerous lesions that can progress to squamous cell carcinoma if left untreated, making effective field-directed therapies important for preventing skin cancer progression.
The trial design is scientifically robust, evaluating treatment across varying surface areas (80-240 cm²) using 1-3 tubes of product, which addresses practical clinical scenarios physicians encounter. The inclusion of a potential second treatment at 12 weeks for non-responders mirrors real-world clinical practice patterns.
Photodynamic therapy offers distinct advantages for field treatment of multiple AKs compared to alternatives like cryotherapy or topical agents. PDT's ability to target subclinical lesions while preserving cosmetic outcomes makes it particularly valuable for larger treatment areas—exactly what this trial aims to validate.
The one-year follow-up period is appropriate for assessing durability of response. From an oncology prevention standpoint, expanding effective field treatments beyond the face and scalp addresses a critical gap in current AK management, potentially reducing progression to invasive squamous cell carcinoma in patients with extensive actinic damage on multiple body sites.
- 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 cm2
- 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 240cm2. 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
FAQ
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