Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)
Biofrontera Inc. (BFRI) has achieved a significant milestone in its Phase 3 study of Ameluz-PDT for treating superficial Basal Cell Carcinoma (sBCC), with the last patient completing the 1-year follow-up in December 2024. The study, involving 187 patients, demonstrated highly statistically significant results (p <0.0001) for all primary and secondary endpoints in October 2024.
The double-blind, randomized, placebo-controlled trial evaluated patients with confirmed sBCC who received either Ameluz-PDT or placebo-PDT treatments. The company plans to submit an sNDA to the FDA in Q3 2025, including the one-year follow-up data. While this data supports the FDA submission, patients will be monitored for a total of five years due to risks of local recurrence.
BCC represents the most common skin cancer in the US, with over 3 million cases annually, making this potential treatment expansion significant for Biofrontera's market presence.
Biofrontera Inc. (BFRI) ha raggiunto un traguardo significativo nel suo studio di Fase 3 su Ameluz-PDT per il trattamento del Carcinoma Basocellulare Superficiale (sBCC), con l'ultimo paziente che ha completato il follow-up di un anno a dicembre 2024. Lo studio, che ha coinvolto 187 pazienti, ha dimostrato risultati altamente significativi dal punto di vista statistico (p <0.0001) per tutti gli endpoint primari e secondari a ottobre 2024.
Lo studio, in doppio cieco, randomizzato e controllato con placebo, ha valutato pazienti con sBCC confermato che hanno ricevuto trattamenti con Ameluz-PDT o placebo-PDT. La società prevede di presentare una sNDA alla FDA nel terzo trimestre del 2025, includendo i dati del follow-up di un anno. Anche se questi dati supportano la presentazione alla FDA, i pazienti saranno monitorati per un totale di cinque anni a causa dei rischi di recidiva locale.
Il BCC rappresenta il cancro della pelle più comune negli Stati Uniti, con oltre 3 milioni di casi annualmente, rendendo questa potenziale espansione del trattamento significativa per la presenza di Biofrontera nel mercato.
Biofrontera Inc. (BFRI) ha alcanzado un hito significativo en su estudio de Fase 3 de Ameluz-PDT para el tratamiento del Carcinoma Basocelular Superficial (sBCC), con el último paciente completando el seguimiento de un año en diciembre de 2024. El estudio, que involucra a 187 pacientes, demostró resultados altamente significativos estadísticamente (p <0.0001) para todos los puntos finales primarios y secundarios en octubre de 2024.
El ensayo, doble ciego, aleatorizado y controlado con placebo, evaluó a pacientes con sBCC confirmado que recibieron tratamientos con Ameluz-PDT o placebo-PDT. La compañía planea presentar una sNDA a la FDA en el tercer trimestre de 2025, incluyendo los datos de seguimiento de un año. Aunque estos datos apoyan la presentación a la FDA, los pacientes serán monitoreados durante un total de cinco años debido a los riesgos de recurrencia local.
El BCC representa el cáncer de piel más común en los EE. UU., con más de 3 millones de casos anuales, lo que hace que esta potencial expansión del tratamiento sea significativa para la presencia de Biofrontera en el mercado.
Biofrontera Inc. (BFRI)는 표재성 기저 세포 암종(sBCC) 치료를 위한 Ameluz-PDT의 3상 연구에서 중요한 이정표를 달성하였으며, 마지막 환자가 2024년 12월에 1년 후속 관찰을 완료했습니다. 187명의 환자가 참여한 이 연구는 2024년 10월에 모든 주요 및 부차적 지표에 대해 통계적으로 매우 유의미한 결과(p <0.0001)를 보여주었습니다.
이중 맹검, 무작위 배정, 위약 대조 시험에서는 확인된 sBCC 환자가 Ameluz-PDT 또는 위약-PDT 치료를 받았습니다. 회사는 2025년 3분기에 FDA에 sNDA를 제출할 계획이며, 1년 후속 데이터도 포함될 것입니다. 이러한 데이터는 FDA 제출을 지지하지만, 환자는 국소 재발 위험으로 인해 총 5년 동안 모니터링될 것입니다.
BCC는 미국에서 가장 흔한 피부암으로 매년 300만 건 이상의 사례가 발생하여 Biofrontera의 시장 존재에 대한 잠재적인 치료 확장이 중요합니다.
Biofrontera Inc. (BFRI) a atteint une étape importante dans son étude de phase 3 sur Ameluz-PDT pour le traitement du carcinome basocellulaire superficiel (sBCC), le dernier patient ayant terminé le suivi d'un an en décembre 2024. L'étude, impliquant 187 patients, a démontré des résultats hautement significatifs sur le plan statistique (p <0.0001) pour tous les paramètres principaux et secondaires en octobre 2024.
L'essai contrôlé, randomisé et en double aveugle a évalué des patients atteints de sBCC confirmé qui ont reçu soit des traitements Ameluz-PDT, soit des traitements placebo-PDT. La société prévoit de soumettre une sNDA à la FDA au troisième trimestre 2025, comprenant les données du suivi d'un an. Bien que ces données soutiennent la soumission à la FDA, les patients seront surveillés pendant un total de cinq ans en raison des risques de récidive locale.
Le BCC représente le cancer de la peau le plus courant aux États-Unis, avec plus de 3 millions de cas par an, ce qui rend cette expansion potentielle du traitement significative pour la présence de Biofrontera sur le marché.
Biofrontera Inc. (BFRI) hat einen bedeutenden Meilenstein in seiner Phase-3-Studie zu Ameluz-PDT zur Behandlung von oberflächlichem Basalzellkarzinom (sBCC) erreicht, wobei der letzte Patient im Dezember 2024 die 1-Jahres-Nachuntersuchung abgeschlossen hat. Die Studie, an der 187 Patienten teilnahmen, zeigte im Oktober 2024 hochgradig statistisch signifikante Ergebnisse (p <0.0001) für alle primären und sekundären Endpunkte.
Die doppelt verblindete, randomisierte, placebokontrollierte Studie evaluierte Patienten mit bestätigtem sBCC, die entweder Ameluz-PDT oder Placebo-PDT-Behandlungen erhielten. Das Unternehmen plant, im 3. Quartal 2025 einen sNDA bei der FDA einzureichen, einschließlich der Daten zur Nachuntersuchung von einem Jahr. Obwohl diese Daten die FDA-Einreichung unterstützen, werden die Patienten insgesamt fünf Jahre lang überwacht wegen des Risikos einer lokalen Wiederauftretens.
BCC ist der häufigste Hautkrebs in den USA, mit über 3 Millionen Fällen jährlich, was diese potenzielle Behandlungserweiterung für die Marktpräsenz von Biofrontera erheblich macht.
- Achieved highly statistically significant results (p <0.0001) for all primary and secondary endpoints
- Completed important 1-year follow-up milestone for FDA submission
- Targeting large market opportunity with over 3 million BCC cases annually in US
- On track for FDA submission in Q3 2025
- Extended five-year follow-up period required, indicating long regulatory pathway
- Additional treatments needed for incompletely resolved lesions after 3 months
Insights
The completion of the 1-year follow-up in Biofrontera's Phase 3 study represents a critical milestone in expanding Ameluz-PDT's treatment scope. The trial's robust design with 187 patients and highly significant results (p<0.0001) for all endpoints strongly positions the therapy for FDA approval in superficial basal cell carcinoma treatment.
The market opportunity is substantial - with over 3 million BCC cases annually in the US. Ameluz-PDT could capture a meaningful share of the sBCC treatment market, particularly given its non-invasive nature and the demonstrated efficacy in the Phase 3 trial. The planned FDA submission in Q3 2025 sets a clear regulatory timeline.
For everyday understanding: Think of this like developing a powerful flashlight that, when combined with a special cream, can effectively treat a common type of skin cancer without cutting into the skin. The study showed this works remarkably well and now they've tracked patients for a full year to prove it stays effective long-term.
This development significantly strengthens Biofrontera's market position in dermatological treatments. The expansion into sBCC treatment could substantially increase Ameluz-PDT's market potential, especially considering the large addressable market of 3+ million annual BCC cases. For a company with a market cap of just
The completion of the 1-year follow-up with positive data reduces regulatory risk and increases the probability of FDA approval. While the full commercial impact won't materialize until after potential FDA approval following the Q3 2025 submission, this milestone should positively influence investor sentiment and the company's valuation metrics.
Simply put: This small company has successfully completed an important step in getting their skin cancer treatment approved for a much bigger use. Given their tiny size compared to the huge market they're targeting, this could mean significant growth potential if they get FDA approval.
- 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 year1.
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. 1
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
FAQ
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