A novel oral immunotherapy for chronic visceral pain of irritable bowel syndrome

Z. Yang
Fzata, Inc., Maryland, United States

Keywords: Irritable bowel syndrome, chronic visceral pain, oral immunotherapy, probiotic

Irritable bowel syndrome (IBS) affects an estimated 10–15% of the US population and costs over $40 billion in medical expenses annually. IBS is often associated with posttraumatic stress disorder (PTSD), depression, and anxiety and is estimated to affect one-third of military women. Chronic abdominal pain (CAP) is a chief complaint in IBS patients and negatively influences patients’ productivity and quality of life. Unfortunately, the current pharmacological approaches for CAP often have a poor outcome and are associated with side effects. Therefore, innovative solutions for a safe, effective, and non-addictive treatment for CVP are critically needed and have great dual-use potential. Fzata has developed a novel live biotherapeutic, FZ004, an engineered probiotic yeast that is delivered orally via capsules and target gut function for managing CAP. FZ004 was completely safe in several animal species. Oral FZ004 treatment restored gut microbiota and metabolome equilibrium in diseased animals. Most importantly, oral FZ004 exhibited exceptional activity in relieving chronic abdominal pain (CAP) in multiple IBS animal disease models. Our ultimate goal is to develop FZ004 as a dual-use, effective, safe, convenient, and non-addictive oral therapeutic to treat chronic abdominal pain in IBS patients.