First-in-Humans Study Using EVs, Including Exosomes, Slated for Crohn’s Disease Treatment in 2017

According to an October 20, 2016 announcement, Esperite’s business unit The Cell Factory, in collaboration with the Women’s and Children’s Health Department of the University of Padua and the Padua University Hospital (Italy), is developing therapies for inflammatory bowel disease (IBD) using extracellular vesicles (EVs). The first target is Crohn’s disease perianal fistulas in adults. A first-in-man study using EVs, including exosomes, for treatment of Crohn’s disease perianal fistula will start in 2017. Inflammatory bowel disease (IBD) encompasses a spectrum of diseases affecting gastrointestinal tract. The most common are Crohn’s disease and ulcerative colitis. IBD is a chronic and often recurring inflammation of the intestines with unknown cause and limited treatment options. In the most severe cases of Crohn’s disease, the patients suffer from perianal fistulas that significantly affect normal activity and may lead to complications such as an increased risk of cancer and life-threating systemic inflammation. In Europe, the current treatment of Crohn’s disease is focused on anti-TNF-alpha therapy whereas anti-integrin biologics are an alternative available in the U.S. Unfortunately, perianal fistulas often do not respond to these systemic treatments. Several clinical trials are ongoing to target perianal fistulas using allogenic mesenchymal stem cells (MSCs) with very positive results. The approach at Esperite is focused on using extracellular vesicles (including exosomes) derived from mesenchymal stem cells (MSCs) for the first time in the treatment of inflammation responsible for Crohn’s disease perianal fistulas. Esperite has acquired the full rights of a broad patent family enabling MSC-derived EVs to be used in treatment of all autoimmune, chronic, and acute inflammatory diseases.
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