COPENHAGEN, OCTOBER 22, 2018 – UNION, a privately held, clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders, today announced positive results from a Phase 1 Sensitization Study in 240 healthy adult volunteers with ATx201. The study was conducted in the US under IND as a randomized and placebo-controlled study. In comparing the active group to placebo, no signs of sensitization were observed, and no subjects showed any signs of unexpected adverse events.
Dr. Philippe Prokocimer, Chief Medical Officer of UNION commented: "The positive outcome of the sensitization study complements prior safety studies with ATx201, in both animals and humans. We are pleased that the studies support the safety and tolerability of ATx201 in both healthy and abraded skin".
Dr. Morten Sommer, the Chief Scientific Officer further added: “The safety and tolerability of ATx201 is of paramount importance given our focus on atopic dermatitis which is common in children. We express our genuine appreciation to the volunteers whose time and effort are helping the development of a much needed new treatment option”. ATx201 is currently being tested in atopic dermatitis patients, for which results are soon expected”.
UNION has previously completed two other Phase 1 studies with ATx201. One of them evaluated the ATx201 irritation potential in 36 healthy adult volunteers. All treatment regimens came out with positive results in both intact and abraded skin after daily applications for 21 days. The other Phase 1 study assessed the systemic safety, local tolerability of three dermal formulations of ATx201 in 30 healthy volunteers using a split-body design. The volunteers were treated twice daily with either ATx201 or placebo during a 7-day period. This study also demonstrated good safety as well as low systemic absorption of ATx201.
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