Biofrontera announces 1-year follow-up results for its phase III study of photodynamic therapy for actinic keratosis on the extremities and trunk/neck
Leverkusen, Germany, Jan. 14, 2020 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today announced
follow-up results for its Phase III clinical study evaluating the safety and efficacy of photodynamic therapy (PDT) with Ameluz and the BF-RhodoLED lamp for the treatment of actinic keratosis (AK)
on the extremities, trunk and neck. After 12 months, the overall lesion recurrence rates were 14.1% after Ameluz treatment, compared to 27.4% after placebo treatment in the Full Analysis Set (FAS;
11.7% vs. 24.6% in the Per Protocol Set, respectively).
“I am not aware of another pivotal clinical study showing similarly high clearance rates and low recurrence rates for the pharmaceutical treatment of actinic keratoses in the periphery,” commented Biofrontera’s CEO Prof. Hermann Luebbert. “With an overall lesion clearance rate of 77% one year after treatment, Ameluz has once again demonstrated its unreached clinical efficacy.”
The multi-center, randomized, double-blind, intra-individual study included 50 patients at six study sites in Germany, each with four to ten clinically confirmed AK lesions in comparable areas on the right and left side of the extremities and/or trunk/neck. Mild, moderate and severe actinic keratoses were treated with one or, if at least one lesion on each patient’s side persisted after three months, two PDT applications. Each PDT consisted of the application of Ameluz on one side of the patient, and an identically looking, feeling and smelling placebo gel on the other side. PDT illumination with 10 minutes of red light using the BF-RhodoLED lamp followed after a 3-hour incubation with occlusion. The final examination of the patients took place three months after the last PDT. This clinical study phase was followed by a follow-up phase of up to one year after the last PDT, in which recurrence rates and numbers of new AKs and skin tumors were determined.
The results for the primary regulatory endpoint, demonstrating that Ameluz was superior (p<0.0001) to placebo based on its mean total lesion clearance rate of 86% compared to 33% for placebo had been published in a Biofrontera press release on March 20, 2019.
The following table represents the treatment outcome after 3 months and the recurrence rates during one year after the last PDT (FAS).
|Endpoints (all FAS)||
Fully cleared lesions after 3 months