AVONTEC’s drug candidate AVT-02 UE for the treatment of inflammatory skin diseases has entered a multiple dosing Phase I study
This Phase I study will be conducted in Germany. Subjects will be treated for a period of four weeks. Besides safety this study is intended to prove changes of functional parameters of the skin during treatment with the drug candidate AVT 02 UE. The German regulatory authority BfArM has approved the conduct of this Phase I study based on a comprehensive dermal toxicology and pharmacology package as well as the promising results of the clinical studies conducted so far.
Dr. Wolfgang Barth, Chief Development Officer at Avontec said: "This study approval is an important milestone in our development program for AVT-02 UE in inflammatory skin diseases and will be the basis for further clinical efficacy studies. It demonstrates the soundness and validity of our preclinical package together with the excellent safety of AVT-02 UE demonstrated so far."
About AVT-02 UE
Avontec's drug candidate AVT-02 UE for inflammatory skin diseases contains a short, double-stranded oligonucleotide "decoy" that effectively inhibits STAT-1, a transcription factor shown to be strongly involved in the regulation of chronic inflammation. AVT-02 UE reduced inflammation in several pharmacological animal models and has demonstrated statistically significant efficacy on relevant clinical endpoints in a pilot proof of concept Phase IIa study in psoriasis. In addition, AVT-02 UE was proven to be safe and well tolerated.