According to GlobeNewswire, Tiziana Life Sciences and Parexel Biotech have agreed to collaborate on a Phase 1b/2 trial of foralumab, an oral treatment for Crohn’s disease. As previous research has shown that this therapy is well-tolerated and provides clinical benefit, both companies are very excited to work together to continue development.
About Crohn’s Disease
Crohn’s disease falls under the larger umbrella of inflammatory bowel disease, and it is characterized by inflammation in the digestive tract. While the entirety of the tract can be impacted, the colon and ileum are most commonly inflamed. This results in symptoms such as diarrhea, abdominal pain, fatigue, weight loss, mouth sores, blood in the stool, cramping, fever, reduced appetite, and pain and drainage around the anus. Complications can arise, with examples like ulcers, anal fissures, colon cancer, and malnutrition. Medical professionals are unsure as to what causes this condition, but they suspect that it is a combination of genetics and a response from the immune system.
About the Study
Tiziana and Parexel will work together on a Phase 1b/2 trial to evaluate the safety, clinical activity, and tolerability of foralumab, which is an enteric-coated capsule. Foralumab is the first and only fully human anti-CD3 monoclonal antibody to treat moderate to severe Crohn’s disease. Its capsule form makes it much easier for patients to take while still treating inflammation.
Previous research in the Phase 1 portion of the trial proved that this treatment is well-tolerated and results in an anti-inflammatory response. It also suggested that foralumab may be a treatment option for those with ulcerative colitis.
As the number of people with inflammatory bowel disease is rising across the world, there is a severe need for viable treatments. Hopefully this study ends successfully, providing another therapy for Crohn’s disease patients.