Biofrontera Shares Positive Results From Phase 3 Trial of Ameluz for Therapy of Actinic Keratoses
Biofrontera (BFRA), an international biopharmaceutical company, on Tuesday shared positive results from a trial for the treatment of actinic keratoses on the extremities or trunk and neck.
Patients were treated with Ameluz on one side of the body and with a placebo gel on the other side.
According to a statement, significant superiority of Ameluz was demonstrated for all secondary parameters investigated, which is in line with the result for the primary endpoint of the study and showed efficacy of 86% for Ameluz compared to 33% for placebo.
Only considering moderate actinic keratoses, lesion clearance rates per patient’s side were 84% with Ameluz compared to 27% with placebo. In patients treated on the extremities, lesion clearance rates per side also were 84% with the drug compared to 27% with placebo.
Some 67% of patients’ sides completely cleared 12 weeks after the last treatment versus 12% of those treated with placebo, the study said.
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The results support the primary endpoint data for the applications to the European Medicines Agency and US Food and Drug Administration, which Biofrontera plans to submit during the third quarter.