Biofrontera reports secondary endpoint results from Phase 3 PDT study

Biofrontera reported results for the secondary endpoints of its Phase 3 clinical trial evaluating the safety and efficacy of conventional photodynamic therapy, or PDT, with Ameluz in combination with the BF-RhodoLED lamp for the treatment of actinic keratoses, or AK, on the extremities or trunk/neck. Patients were treated with Ameluz on one side of the body and with a placebo gel on the other side. In line with the result for the primary endpoint of the study, which showed a mean lesion clearance rate per patient’s side of 86% for Ameluz compared to 33% for placebo, superiority of Ameluz was demonstrated for all secondary parameters investigated. Even if mild AKs were ignored and only moderate AKs were considered, mean lesion clearance rates per patient’s side were 84% with Ameluz compared to 27% with placebo. In patients treated on the extremities, mean lesion clearance rates per patient’s side were also 84% with Ameluz compared to 27% with placebo. Mean lesion clearance rates in the area trunk/neck were even higher. Furthermore, the comparison parameter “patient complete clearance” also emphasized the superiority of Ameluz: 67% of the patients’ sides were completely cleared 12 weeks after the last PDT compared to 12% of the placebo-treated sides. All of the results were statistically highly significant. Thus, all secondary endpoints also confirm the superiority of Ameluz over the control group. These results support the primary endpoint data for the applications to the European Medicines Agency and FDA, which Biofrontera plans to submit during Q3.

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