Biofrontera Inc. Completes Patient Enrollment in Phase 3 Study
WOBURN, Mass. — Biofrontera Inc. (NASDAQ: BFRI), a leading biopharmaceutical company renowned for its innovations in photodynamic therapy (PDT), has successfully announced the completion of patient enrollment in its pivotal Phase 3 clinical trial. This trial is specifically focused on evaluating Ameluz® (aminolevulinic acid hydrochloride) as an effective treatment for mild to moderate actinic keratoses (AKs) that occur on the extremities, neck, and trunk.
The Significance of Actinic Keratosis Treatment
Actinic keratosis is a widespread skin condition resulting from prolonged sun exposure. Without intervention, these lesions can escalate into more severe forms of skin cancer, like squamous cell carcinoma. It is crucial to address this pervasive issue, as AKs are frequently observed in delicate sun-exposed areas. By expanding treatment options beyond facial and scalp applications, Biofrontera is tackling a significant gap in dermatology, thus providing alternative solutions to healthcare professionals and patients alike.
Details of the Clinical Trial
This comprehensive trial is designed as a multicenter, randomized, double-blind study, aimed at comparing the efficacy of Ameluz® against a vehicle in treating actinic keratoses located on the extremities, neck, and trunk. Patients in the study will undergo PDT using either the Ameluz® gel or the vehicle gel, facilitated with a RhodoLED lamp (either BF-RhodoLED® XL or BF-RhodoLED®). The protocol involves administering one to two treatments, depending on the persistence of lesions on the treated area, with careful monitoring of the results.
Trial Structure and Patient Engagement
A total of 172 patients have been enrolled in the study, with a treatment allocation ratio of 4:1 favoring Ameluz®. Each participant receives one primary treatment session, followed by potential re-treatment after 12 weeks if lesions remain. An extensive follow-up period of approximately one year after the last treatment will provide invaluable data on the safety and long-term efficacy of the treatment.
Expert Insights and Anticipated Outcomes
Dr. Hermann Luebbert, the CEO and Chairman of Biofrontera Inc., expressed enthusiasm regarding the milestone of this trial. He stated, “Reaching this pivotal stage in our clinical program brings us closer to an effective solution for patients battling actinic keratoses on other parts of the body, marking a notable advancement for the applications of Ameluz®.”
Further underscoring the relevance of this study, Dr. Nathalie Zeitouni, a Mohs surgeon and principal investigator, noted the pressing need for effective treatments beyond the already established uses of Ameluz® on the face and scalp, making this study a beacon of hope for many patients suffering from AKs on their bodies.
Looking Ahead: Future Steps
With the enrollment phase now behind them, Biofrontera aims to conclude the treatment phase of the study by September 2025, followed by a detailed follow-up scheduled to wrap up by the second quarter of 2026. Should the trial yield positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the FDA in late 2026, seeking to broaden the application of Ameluz® and improve patient care in dermatological conditions.
About Biofrontera Inc.
Biofrontera Inc. is focused on addressing dermatological conditions, utilizing photodynamic therapy as a cornerstone of its development strategy. The company is pioneering efforts to extend its treatments for not only actinic keratoses but also aims to address other significant skin conditions through ongoing clinical trials. Ameluz® is marketed in conjunction with the RhodoLED® lamp series to ensure effective preventive and therapeutic measures against pre-cancerous skin lesions.
Frequently Asked Questions
What is Ameluz® used for?
Ameluz® is primarily used for the treatment of actinic keratoses, a pre-cancerous skin condition caused by sun exposure.
When is the final result of the clinical trial expected?
The treatment phase is projected to finish by September 2025, with a comprehensive follow-up concluding by Q2 2026.
What is the significance of PDT in dermatology?
PDT is a significant therapeutic approach as it effectively targets and treats skin lesions, offering a minimally invasive method for addressing skin conditions.
How many patients participated in the trial?
A total of 172 patients were enrolled in the trial to evaluate the efficacy of Ameluz® against a vehicle gel.
What are the future plans for Biofrontera Inc.?
Biofrontera Inc. intends to submit a supplemental New Drug Application to the FDA if the trial shows positive results, thereby expanding the use of Ameluz®.
