We are delighted to announce the Belgian Federal Agency for Medicines and Health Products (FAMHP) has approved the clinical trial application (CTA) for our lead candidate, EXL01, a single strain Live Biotherapeutic Product (LBP) using the gut bacteria Faecalibacterium prausnitzii for the treatment of Crohn’s Disease.
Prof. Harry Sokol, Professor of Gastroenterology at Saint-Antoine Hospital in Paris (APHP) and acting Chief Medical Officer of Exeliom Biosciences, "Almost 15 yearsago, we discovered the drastic reduction of the amount of Faecalibacterium prausnitzii inpatients with inflammatory bowel diseases, its connection with diseaserecurrence, and its powerful anti-inflammatory effects. Many teams around theworld confirmed the strong therapeutic potential of Faecalibacterium prausnitzii, stimulating the enthusiasm ofpatients and physicians for this new therapeutic candidate. Many more years ofintense research, in collaboration with Dr. Philippe Langella at INRAE andProf. Patrick Gervais at AgroSup Dijon, were needed to understand the underlying mechanismsand to overcome the manufacturing challenges. Now, with the green light tostart the first human study in Crohn's disease with EXL01, we are reaching acritical milestone in this journey, and I am delighted that we are able to assessthis promising candidate in patients.”