COPENHAGEN, APRIL 05, 2017 – AntibioTx, a clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders, today declared successful completion of a Phase I study with ATx201. The Study set out to determine the systemic and local exposure of three different formulations of ATx201 in 36 healthy volunteers. “We are pleased about the top-line data which show no signs of unexpected adverse events. Furthermore, pharmacokinetic data from biopsies and plasma samples are very encouraging”, said Rasmus Toft-Kehler, CEO of AntibioTx. CSO, Morten Sommer, further added “These results support the continued development of ATx201 for a variety of skin conditions including atopic dermatitis. We are thankful for the hard work and wanted to express our great appreciation to the clinicians, partners, staff, and volunteers who all contributed significantly to make this study possible”.
About the DECOLAD Phase I Study
The DECOLAD Phase I study assessed overall safety, local tolerability, pharmacokinetics (PK) in three dermal formulations of ATx201 and was a prospective, randomized, double-blind, placebo controlled study in 36 healthy subjects. Subjects were treated at four separate skin areas, 5 cm in diameter, twice daily with either ATx201 or placebo in a 7-day period. The pharmacokinetic analysis involved blood samples in order to evaluate the systemic exposure and skin biopsies to assess local exposure to the skin. The study was conducted by the Department of Clinical Pharmacology, Medical University of Vienna, Austria.
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