Roivant Sciences recently shared updates on the Phase 2b TUSCANY-2 study. Within the study, the team was evaluating RVT-3101 for moderate-to-severe ulcerative colitis. RVT-3101 is a fully human monoclonal antibody, administered subcutaneously, that targets TL1A; TL1A signaling has been linked to inflammation. By reducing TL1A signaling, RVT-3101 is designed to similarly reduce inflammation within the large intestine.
Multiple RVT-3101 doses were tested within the TUSCANY-2 study. The recommended dose for a planned Phase 3 study is still unknown. Following a 56-week period, promising results emerged. 50% of trial participants saw their disease severity improve, becoming mild (or disappearing altogether). 21% of people had completely inactive ulcerative colitis. More so, 36% of participants achieved clinical remission. This means that signs or symptoms of the disease are basically gone.
RVT-3101 was safe, with no lasting safety concerns. It was also tolerated well, with few serious side effects.
About Ulcerative Colitis
Ulcerative colitis is a chronic form of inflammatory bowel disease. It is characterized by the formation of large intestine sores and ulcers, most often in the colon and rectum. Younger adults, as well as people over 60 years old, are more susceptible to developing ulcerative colitis. Ashkenazi Jewish heritage and a family history of inflammatory bowel disease also increase the risk. Ulcerative colitis can cause severe and life-threatening complications. Treatments are available to reduce symptoms and induce remission.
People living with ulcerative colitis may experience symptoms such as:
- Rectal pain
- Bloody stool
- Diarrhea
- A feeling of fullness in the bowels
- Abdominal pain and cramping
- Joint pain
- Fatigue
- Fever
- A sense of fecal urgency
- Unintended weight loss
- Rash
- Anemia (low red blood cell count)
- Nausea
Severe bleeding, severe dehydration, colon perforations, toxic megacolon, blood clots, osteoporosis, and an increased risk of colon cancer are all complications. If you are experiencing sudden and severe symptoms, emergency treatment may be necessary. Your treatment plan may include a variety of interventions such as corticosteroids, antibiotics, aminosalicylates, corticosteroids, immunomodulators, and surgery in serious cases.
