Clinical study with BioFrontera's BF-derm1 shows efficacy in severe chronic urticaria
Biofrontera AG announced that it has received the results of an adaptive phase II study with BF-derm1 in chronic urticaria patients who cannot be sufficiently treated with current medication. The study has demonstrated very good efficacy and safety for the orally available BF-derm1 tablets.
The adaptive trial was composed of three parts. Positive interim reports were already reported for the two initial parts. These first parts mostly served to determine the dosis of the active compound for the third part of the trial, in which the efficacy and safety of BF-derm1 was evaluated. Since the two higher concentrations showed the best effects during the 8-week treatment period, the highest concentration was used in the ultimate part of the trial.
In its entirety the study has demonstrated that BF-derm1 alleviates the symptoms of severe chronic urticaria and concomitantly considerably reduces the intake of sedating antihistaminic co-medication. To the contrary, patients treated with a placebo medication took increasing amounts of antihistaminics to ease their symptoms during the course of the study. The most frequent side effects were sedation and headache, which were, however, not dose-related and also occurred in the placebo group.
On the basis of these positive results Biofrontera intends to find a license partner for its product candidate BF-derm1. The clinical development of this promising product candidate will then be continued jointly.
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