Biofrontera enrolled first patient in phase II study of BF-37 in atopic dermatitis
Biofrontera AG (DSE: B8F) announced that the responsible authorities gave their permission to conduct a clinical phase II study of BF-37, and that the first patient has been included. The placebo-controlled study will monitor the efficacy of BF-37 in atopic dermatitis, as well as the tolerability and safety of the crème.
In the study, diseased skin of 30 patients will be treated with BF-37 crème. Other dermatitis plaques are treated with placebo and serve as control. The study is conducted by bioskin GmbH, Hamburg, an independent CRO with extensive experience in dermatology. Treatment success will be monitored during and after 4 weeks of treatment, applying clinical symptom scales and physiological parameters.
BF-37 inhibits the proliferation of T-cells. An increased proliferation of these immune cells is believed to cause atopic dermatitis. Biofrontera assumes that BF-37 interferes directly with cellular processes of the immune system of the skin, thereby diminishing the inflammation that underlies the reddening and itching. BF-37 has already been shown to be effective in an animal model of atopic dermatitis.
The active ingredient of BF-37 is on the market as a tablet for another indication since several years. Its safety and tolerability were demonstrated in clinical studies and through the clinical use of the compound. Subsequent to Biofrontera's current study, it is planned to test BF-37 in larger phase III studies for atopic dermatitis. An exploratory phase II study with BF-37 for psoriasis is in preparation.
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