Biofrontera concludes clinical phase III of BCC study. Approval of Ameluz expected in 2016November 19, 2015
Biofrontera has concluded the clinical phase 3 of basal cell carcinoma (BCC) study as the last patient in the ongoing phase has had its final clinical visit.
Biofrontera said on Thursday it expected preliminary results of the main clinical endpoints before the end of the year and the final report by the end of Q1 2016.
Biofrontera explains that its study focusses on thin, non-aggressive BCCs, which may represent about one-third of all BCCs – the most common infiltrating tumor in humans.
Ameluz superior to Metvix
The study compares the efficacy and safety of Ameluz with those of Metvix, a drug approved in the EU for the treatment of superficial and nodular BCCs against which Ameluz is already showing superior results for other indications. The primary clinical endpoint is for Ameluz to deliver total clearance of all patient’s BCCs.
The Leverkusen-based company added that the clinical study would be followed by a five year follow-up period, during which recurrence of treated BCCs as well as new BCCs and other skin tumors will be recorded.
Approval of Ameluz expected in 2016
Prof. Dr. Hermann Luebbert, CEO of Biofrontera commented: “The data from this phase III study will allow us to obtain approval for BCC treatment with Ameluz in Europe, which technically is a variation of the existing centralized approval. The agency’s decision on such a variation takes three months from the application plus the time required to answer questions of the agency.
“We anticipate the approval in the summer of 2016 and subsequently envision a significantly larger market potential for Ameluz”