According to a press release from French biotechnology company Abivax, the Company has successfully begun recruitment for its phase 2b clinical study of ABX464, its experimental once-a-day ulcerative colitis medication.
About Ulcerative Colitis
Ulcerative colitis is a form of irritable bowel disease characterized by the formation of painful ulcers along the digestive tract, along with general inflammation and discomfort. The condition is mostly concentrated along the most interior lining of the large intestine.
Ulcerative colitis can be hard to detect at first, as it generally worsens over a length of time. Treatment can reduce the severity and frequency of flare-ups, but even today there is no cure for ulcerative colitis. If left untreated, the condition can even lead to fatal health complications.
It may surprise you to know that physicians and researchers still aren’t sure what exactly causes ulcerative colitis. Some theorize that it may be an immune disorder, where the body’s immune system mistakenly starts to attack healthy tissues and organs as though they were pathogens. Some think genetics might influence development, though most with the condition have idiopathic cases and no known family history of ulcerative colitis.
ABX464 and the Phase 2b Study
Earlier this week week, Abivax announced that it has already recruited the first patient in the randomized, double-blind study. The company hopes to recruit 232 ulcerative colitis patients at a number of locations in as many as fifteen countries.
Participants will be sorted into active groups and a control group. Every day, they will receive the same dose of one of three possible quantities of ABX464 or a placebo. The study will last for approximately 4 months (16 weeks), and will be accompanied later by an open-label extension study of the experimental drug.
ABX464 is believed to reduce inflammation by acting on an area of RNA in cells. Specifically, this area is called the cap binding complex, which plays an important role in numerous gene activities including transcription, splicing, and translation. ABX464 “enhances the selective splicing” of a section of “non-coding RNA” to generate an anti-inflammatory microRNA called miR-124. Abivax believes miR-124 may act by regulating the activity of certain inflammatory cytokines, which may be a cause of ulcerative colitis’ characteristic inflammation.
Do you or does anyone you know live with ulcerative colitis? What do you think of this exciting development? Share your thoughts with Patient Worthy!