Three phase III trials show efficacy of BF 200 ALA (5-aminolevulinic acid) in actinic keratosis- Biofrontera
Biofrontera has presented data from three pivotal Phase III trials for its lead drug candidate BF 200 ALA (5-aminolevulinic acid) which demonstrate very high efficacy, positive safety and excellent aesthetic outcomes using photodynamic therapy (PDT) for the topical treatment of actinic keratosis (AK). In the three Phase III trials a total of 779 patients with 4 to 8 mild to moderate AK lesions were randomized, with all three studies using red light PDT.
One 122-patient Phase III study demonstrated excellent efficacy of BF-200 ALA compared to placebo with a patient complete clearance rate of 87%, compared to placebo response of 13%. A second Phase III study of 571 patients showed significantly improved patient clearance rates for BF-200 ALA (85%) compared to those of placebo (13%) and methylaminolevulinate (MAL) (68%), which is marketed as Metvix and was the current standard of care topical photosensitizing agent used in PDT.
A 1-year follow-up showed slightly lower recurrence rates for BF-200 ALA compared to MAL, and PDT side effects were not enhanced using BF-200 ALA. The third, 86-patient, Phase III study compared efficacy and cosmetic outcome of BF-200 ALA with placebo, finding that 91% percent of the patients completely cleared after a maximum of two treatments with BF-200 ALA, compared to only 22% complete clearance with placebo. With BF-200 ALA treatment, clearance was sustained over one year of follow-up in 63.3% of the patients.
Two of the studies formed the basis for marketing authorization approval of BF-200 ALA as first-line treatment of mild to moderate actinic keratosis on the face and scalp by the European Medicines Agency in December 2011. The third study was performed to strengthen the New Drug Application submitted to the FDA in July 2015. Filing of the application was accepted in September, since when the FDA undertakes its substantive review. No review issue was reported by the FDA following their mid-term review meeting. Data were presented at the 14th Annual South Beach Symposium.
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