Successful Phase III trial of Ameluz (5-aminolevulinic acid) with photodynamic therapy to treat actinic keratosis.- Biofrontera AG

Biofrontera AG announced detailed results from its Phase III clinical trial evaluating the safety and efficacy of its topical prescription drug Ameluz in combination with daylight photodynamic therapy (PDT). The study met its primary endpoints, demonstrating that Ameluz in combination with daylight PDT was non-inferior to standard of care Metvix for the treatment of mild to moderate actinic keratosis (AK), a superficial skin cancer.

Furthermore, Ameluz compared favorably to Metvix in all secondary endpoints. These results will serve as the basis for the filing for EU label extension, which Biofrontera intends to submit during the second quarter of 2017. The study met its primary endpoint, exhibiting a total lesion clearance rate (percentage of completely cleared individual lesions per patient’s side) of 78.7% for the areas treated with Ameluz; demonstrating non-inferiority to Metvix, where 75.0% of lesions were fully cleared after one daylight PDT (p<0.0001). Histological evaluation of lesion clearance resulted in a similar outcome, with 72.5% versus 66.7% of lesions fully cleared after treatment with Ameluz and Metvix, respectively.

All secondary endpoints compared favorably with Metvix and showed equivalent or better clearance rates. 85% of lesions on the face were fully cleared after a single PDT with Ameluz , and 72% of the more difficult to treat lesions were fully cleared on the scalp. For Metvix , 84% and 65% of the lesions were fully cleared on face and scalp, respectively. The treatment of moderate AK lesions resulted in 76% fully cleared with Ameluz, compared to 73% with Metvix. Mild AK lesions had a clearance rate of 94% with Ameluz and 91% with Metvix. Lesions in patients with greater than 5 AKs were fully cleared in 83% of cases with Ameluz and 81% with Metvix, while 77% versus 72% of lesions were fully cleared in patients with more than 5 AKs by Ameluz and Metvix treatment, respectively. The most notable differences between Ameluz and Metvix clearance rates were observed in patients younger than 65 years of age (83% vs. 74%) and for patients treated during cloudy weather (75% vs. 66%), respectively. Results of daylight PDT during sunny weather conditions improved lesion clearance rates to 85% with Ameluz and 83% with Metvix. Complete clearance of all lesions was achieved by Ameluz in 60% of patients with lesions on the face, compared to 50% for Metvix treated patients. Patients with scalp lesions were fully cleared of all keratoses in 33% and 26% of cases using Ameluz or Metvix respectively. There were no notable differences in side effects.