Patient recruitment in Biofrontera's phase II study in severe chronic urticaria completed
Biofrontera AG announced that patient enrolment in the third and final part of the clinical phase II study with Biofrontera's product candidate BF-derm1 is completed. BF-derm1 is a tablet for the treatment of patients with severe, hitherto not satisfactorily treatable chronic urticaria. The placebo controlled trial is conducted following an adaptive design with three study parts. In the first two parts dose finding and safety were examined, in the final part the efficacy is tested by comparing treatment and placebo with 51 patients. The clinical trial is conducted in three study centers in Berlin and Moscow under the clinical supervision of Dr. Dr. W. Greb, Managing Director of Focus Clinical Drug Development GmbH.
In the study, patients are treated with BF-derm1 over a period of 8 weeks, followed by an 8-week medical observation period. With the last patient now enrolled, Biofrontera anticipates the completion of treatment in the middle of March next year. Thereafter, the data clean-up and analysis can take place.
BF-derm1 inhibits the enzyme histidine decarboxylase, which is responsible for the final step of histamine synthesis. Histamine is a major trigger for allergic symptoms such as itching, wheals or flushing of the skin. Biofrontera develops BF-derm1 for the treatment of chronic, severe antihistamine-refractory urticaria.
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