ABIVAX announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for their lead drug candidate ABX464, allowing the initiation of clinical trials in the U.S. in patients with moderate-to-severe ulcerative colitis (UC). The first U.S. patients are expected to be enrolled in the ongoing Phase 2b clinical trial ABX464-103, in the second quarter of 2020. Under the leadership of Prof. S-verine Vermeire, M.D., Ph.D., Head of the IBD Center at the University Hospitals Leuven, Belgium, ABX464 is currently being tested in 15 European countries and in Canada in patients with moderate-to-severe UC. This ongoing Phase 2b clinical trial (ABX464-103) in 232 patients will now be extended to the U.S. Recently published data from the Phase 2a 12 months open label maintenance study showed that 75% of the patients with moderate-to-severe active UC, who had failed on immunomodulators, anti-TNF?, vedolizumab and/or corticosteroids, were in clinical remission (meaning essentially symptom free). In all clinical trials, ABX464 was safe and well tolerated. There were no serious adverse drug reactions reported. Adverse events were typically of mild to moderate intensity. The most common reported adverse events reported were headache, abdominal pain and diarrhea.