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.

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.