Phase 3 Data for BF-200 ALA Presented at the 14th South Beach Symposium

Biofrontera AG’s BF-200 ALA plus red light photodynamic therapy (PDT) shows good efficacy for the treatment of actinic keratoses (AK), according to data presented from three pivotal Phase III trials at the 14th Annual South Beach Symposium. The results were presented in a poster (Poster #118) and were highlighted during two oral presentations.

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.

In the three Phase III trials conducted in centers in Germany, Switzerland and Austria, a total of 779 patients with 4 to 8 mild to moderate AK lesions were randomized, with all three studies using red light PDT with LED illumination sources at approximately 635 nanometers (nm).

 • A 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%.1

 • A 571-patient Phase III study 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.2

 • An 86-patient Phase III study used a field directed approach (the entire tube of BF-200 ALA was applied to a field of cancerized skin) and compared efficacy and cosmetic outcome of BF-200 ALA with placebo, finding that 91% percent of the patients.