Alicaforsen is an antisense oligonucleotide targeted to down regulate the production of ICAM-1, a cell surface receptor which is involved in the process of inflammation. Alicaforsen selectively inhibits ICAM‑1 gene expression. Over-expression of ICAM‑1 occurs in a wide variety of inflammatory disorders, including ulcerative colitis (UC), pouchitis and tissues in the eye, gastrointestinal teact, lungs and skin. Alicaforsen is currently in development for the treatment of IBD. An enema formulation is currently in a pivotal Phase 3 study agreed with U.S., Canadian and European regulatory agencies in patients with active pouchitis. The study has completed enrollment of patients to approximately 40 trial centres across the U.S., Canada, Europe, and Israel, and is expected to report preliminary data in H1 2019. Under a rolling submission agreement with the FDA, Atlantic Healthcare has filed the nonclinical data package of its New Drug Application (NDA) for alicaforsen to treat pouchitis with the regulator. Alicaforsen has also been granted FDA Fast-Track designation, plus U.S. and European Orphan Drug designations for this indication. ​