Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC)
Biofrontera announced significant results from its Phase 3 study of Ameluz®-PDT for treating superficial basal cell carcinoma (sBCC). The study involved 187 patients and showed 65.5% success rate with Ameluz®-PDT compared to 4.8% with placebo in achieving complete clinical and histological clearance. Secondary endpoints were also highly significant (p<0.0001), with 64.1% of Ameluz®-PDT patients achieving total clearance of all sBCC lesions versus 4.8% for placebo. Patient satisfaction was notable, with 64.3% rating the treatment as very good and 22.2% as good. The company plans to submit FDA documentation in Q2/Q3 2025 after completing the one-year follow-up phase in December.
Biofrontera ha annunciato risultati significativi dal suo studio di Fase 3 su Ameluz®-PDT per il trattamento del carcinoma basocellulare superficiale (sBCC). Lo studio ha coinvolto 187 pazienti e ha mostrato un 65,5% di successo con Ameluz®-PDT rispetto al 4,8% con placebo nel raggiungimento di una completa guarigione clinica e istologica. Anche i criteri secondari sono stati altamente significativi (p<0,0001), con il 64,1% dei pazienti trattati con Ameluz®-PDT che ha ottenuto la completa guarigione da tutte le lesioni sBCC rispetto al 4,8% per il placebo. La soddisfazione dei pazienti è stata notevole, con il 64,3% che ha valutato il trattamento come molto buono e il 22,2% come buono. L'azienda prevede di presentare la documentazione all'FDA nel secondo/terzo trimestre del 2025 dopo aver completato la fase di follow-up di un anno a dicembre.
Biofrontera anunció resultados significativos de su estudio de Fase 3 sobre Ameluz®-PDT para tratar el carcinoma de células basales superficiales (sBCC). El estudio involucró a 187 pacientes y mostró una tasa de éxito del 65,5% con Ameluz®-PDT en comparación con el 4,8% con placebo para lograr una eliminación clínica e histológica completa. Los criterios secundarios también fueron altamente significativos (p<0,0001), con el 64,1% de los pacientes tratados con Ameluz®-PDT logrando una eliminación total de todas las lesiones de sBCC frente al 4,8% del placebo. La satisfacción de los pacientes fue notable, con el 64,3% calificando el tratamiento como muy bueno y el 22,2% como bueno. La empresa planea presentar documentación a la FDA en el segundo/tercer trimestre de 2025, después de completar la fase de seguimiento de un año en diciembre.
Biofrontera는 표재성 기저세포암(sBCC) 치료를 위한 Ameluz®-PDT의 3상 연구에서 중요한 결과를 발표했습니다. 이 연구는 187명의 환자가 참여하였으며, Ameluz®-PDT와의 65.5% 성공률을 기록했고, 이는 위약의 4.8%에 비해 높은 수치입니다. 임상적 및 조직적 완전 관해에 도달한 것입니다. 2차 목표도 매우 유의미한 결과를 보였으며(p<0.0001), Ameluz®-PDT 환자의 64.1%가 모든 sBCC 병변에 대해 완전 제거를 달성한 반면, 위약으로는 4.8%였습니다. 환자 만족도도 눈에 띄었으며, 64.3%가 치료를 매우 좋다고 평가했고, 22.2%가 좋다고 평가했습니다. 해당 회사는 2025년 2분기/3분기에 FDA 문서를 제출할 계획이며, 12월에 1년 추적 관찰 단계를 완료한 후에 진행할 예정입니다.
Biofrontera a annoncé des résultats significatifs de son étude de Phase 3 sur Ameluz®-PDT pour le traitement du carcinome basocellulaire superficiel (sBCC). L'étude a impliqué 187 patients et a montré un taux de succès de 65,5% avec Ameluz®-PDT par rapport à 4,8% avec un placebo pour atteindre une éradication clinique et histologique complète. Les critères secondaires étaient également hautement significatifs (p<0,0001), avec 64,1% des patients traités par Ameluz®-PDT atteignant une éradication totale de toutes les lésions de sBCC contre 4,8% pour le placebo. La satisfaction des patients était notable, 64,3% évaluant le traitement comme très bon et 22,2% comme bon. L'entreprise prévoit de soumettre la documentation à la FDA au 2e/3e trimestre 2025 après avoir complété la phase de suivi d'un an en décembre.
Biofrontera kündigte bedeutende Ergebnisse aus seiner Phase-3-Studie zu Ameluz®-PDT zur Behandlung von oberflächlichem Basalzellkarzinom (sBCC) an. Die Studie umfasste 187 Patienten und zeigte eine Erfolgsquote von 65,5% mit Ameluz®-PDT im Vergleich zu 4,8% mit Placebo, was die vollständige klinische und histologische Clearance betrifft. Auch die sekundären Endpunkte waren hochsignifikant (p<0,0001), wobei 64,1% der Ameluz®-PDT-Patienten eine vollständige Clearance aller sBCC-Läsionen im Vergleich zu 4,8% für Placebo erreichten. Die Patientenzufriedenheit war bemerkenswert, wobei 64,3% die Behandlung als sehr gut und 22,2% als gut bewerteten. Das Unternehmen plant, die FDA-Dokumentation im 2./3. Quartal 2025 einzureichen, nachdem die einjährige Nachbeobachtungsphase im Dezember abgeschlossen wurde.
- Highly significant primary endpoint achievement (65.5% vs 4.8% placebo)
- Strong histological clearance rate of 75.9% vs 19.0% placebo
- High patient satisfaction rate (86.5% rated good or very good)
- Clear pathway to FDA submission in Q2/Q3 2025
- Treatment requires multiple PDT sessions
- FDA submission still approximately one year away
- 34.5% of patients did not achieve complete clearance
Insights
The Phase 3 trial results for Ameluz-PDT in treating superficial basal cell carcinoma (sBCC) demonstrate exceptional efficacy with highly significant statistical outcomes. The 65.5% complete clearance rate versus
The study's robust design with 187 patients and multiple efficacy endpoints provides compelling evidence for market expansion. With over 3 million BCC cases annually in the US, successful FDA approval could significantly expand Ameluz's market potential beyond its current actinic keratosis indication. The anticipated submission timeline of Q2/Q3 2025 suggests potential market entry by 2026, representing a major catalyst for Biofrontera's growth trajectory.
For a micro-cap company with just
Key market advantages include the non-invasive nature of the treatment, reduced scarring and high patient satisfaction rates (
- First Phase 3 PDT study in patients with sBCC in the United States.
- Primary and secondary endpoints all highly statistically significant p<0.0001
- Correlates to data seen in Europe where sBCC is already incorporated in the Summary of Product Characteristics.
- BCC is the most common skin cancer in the US, with more than 3 million cases each year1.
WOBURN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of PDT, today announced top-line results in its Phase 3 study of the use of Ameluz® with the BF-RhodoLED® lamp in the treatment of sBCC (study ALA-BCC-CT013).
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, repeated after three months, if required.
The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. Ameluz®-PDT achieved
“We are delighted that these highly significant results mirror those found in the European studies,” stated Dr. Hermann Luebbert, CEO and Chairman of Biofrontera. He added, “Once we finish the one-year follow up phase in December, we will be in a position to submit our dossier to the FDA around the end of Q2 / early Q3 of 2025”.
“I have used Ameluz®-PDT in my practice for many years for the treatment of Actinic Keratosis, and we were pleased to be a part of such an extensive and rigorous study to examine its use in patients with superficial BCC,” said Dr. David Pariser of Virginia Clinical Research and Pariser Dermatology, and Coordinating Investigator for the study.
“I am excited that the potential FDA approval may provide me with a new non-invasive option for my patients that may not involve potential scarring, or repeated office visits for ionizing radiation, and which could therefore lead to reduced patient burden and a beneficial cosmetic outcome,” commented Dr. Todd Schlesinger, board certified dermatologist and Mohs surgeon, and main contributor to the study.
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
1 https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
About Biofrontera Inc.
Biofrontera 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 Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers2. 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.
2 https://www.skincancer.org/skin-cancer-information/actinic-keratosis/
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
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