According to a story from IBD News Today, the Food and Drug Administration (FDA) has just issued approval for the pharmaceutical company Immunic Therapeutics to move forward with Phase II trials for IMU-838. This prototype therapy is meant to treat ulcerative colitis. The trial is expected to utilize 150 participants in order to test the effectiveness of various dosage levels of the drug in treating patients with moderate to severe ulcerative colitis.
Ulcerative Colitis (UC) is a chronic, long term inflammatory disease of the digestive tract that results in the formation of ulcers in the rectum and colon. Symptoms may first develop in early adulthood in many cases, ranging from fairly mild to severe. These symptoms include bloody diarrhea, abdominal discomfort, anemia, weight loss, and fever. Inflammation can also spread to other parts of the body and the risk of colon cancer also increases. The cause of the disease is not well understood. The disease symptoms often manifest as flare ups of more severe symptoms alternating with periods in which symptoms decrease in severity or disappear temporarily. To learn more about this disease, click here.
Another Phase II trial will also test the drug’s usefulness in Crohn’s disease, a digestive disease that can manifest in similar ways to UC. IMU-838 is categorized as an immune system modulator. Selective in nature, the treatment targets the function of T-cells and activated B-cells. These cells are responsible for the inflammation that is characteristic of UC. The treatment does not suppress the immune system as a whole, meaning that the risk of viral infection does not increase with use of the drug. This is a common side effect with other immune system regulating treatments.
