A new study being conducted in more than 100 clinical centers across the world is evaluating the safety and efficacy of a new investigational drug for the treatment of mild to severely active ulcerative colitis. The OASIS clinical trial aims to recruit 240 adults, ages 18 to 80 years old, who have been diagnosed with ulcerative colitis for at least six months and have failed to respond to at least one medication.
Ulcerative colitis, a type of inflammatory bowel disease (IBD), is a chronic disease that affects the colon and is characterized by tissue inflammation and ulceration, leading to frequent day-to-day difficulties, such as diarrhea, abdominal cramps, and frequent bowel movements. It is the result of an exacerbated response of the immune system and, therefore, the usual therapy focuses on controlling inflammation via intravenous delivery of anti-inflammatory and immune-suppressive drugs, although current therapies have a few limitations regarding efficacy, side effects, and route of administration.
The development of an oral medication such as the one being studied in the OASIS trial would greatly improve treatment convenience in patients with ulcerative colitis.
The investigational drug, not yet approved by the U.S. Food and Drug Administration (FDA), is APD334, an orally available S1P1 receptor modulator, developed by Arena Pharmaceuticals. It acts by modulating the S1P1 receptor, which has been shown to be involved in a series of biological responses including lymphocyte trafficking from lymph nodes to circulating blood. By toning down this recruitment, the drug causes the immune response to be less aggressive, and consequently reduces the damage caused. APD334 has the therapeutic potential to treat a range of autoimmune diseases, including ulcerative colitis.
According to a press release, the OASIS clinical trial, which will evaluate the drug’s efficacy and safety in reducing gut inflammation, is currently recruiting participants. The trial will be 16 to 18 weeks long, and includes 7 to 10 visits to the study clinic. Study participants will be required to take the medication once a day, undergo endoscopy and biopsy before the study begins, and record disease symptoms in an electronic diary.