Atlantic Healthcare Completes Phase 3 Trial Enrollment for Alicaforsen as Pouchitis Treatment

Atlantic Healthcare Completes Phase 3 Trial Enrollment for Alicaforsen as Pouchitis Treatment
Atlantic Healthcare has completed enrollment for a Phase 3 trial evaluating the safety and efficacy of alicaforsen in patients with pouchitis, a frequent complication after surgery to treat different forms of inflammatory bowel disease (IBD). IBD patients have increased production of ICAM-1 protein, which correlates with intestinal inflammation. Alicaforsen binds specifically to the human ICAM-1 messenger RNA, reducing the amount of ICAM-1 protein that is produced, thus helping to stop the disease-associated inflammation. Launched in August 2015, the randomized, multicenter, double-blind, placebo-controlled trial (NCT02525523) is assessing the safety and efficacy of alicaforsen’s enema formulation in patients with pouchitis in active flare who have failed to effectively respond to therapy, or those who cannot take antibiotics. Enrolled participants include Canadian, U.S., and European ulcerative colitis patients who had undergone ileal pouch-anal anastomosis (IPAA) surgery – a procedure used to restore gastrointestinal continuity after the surgical removal of the colon and rectum, with the construction of a pouch made from a loop of small intestine. Pouchitis is the inflammation of the surgically created pouch. It is the most common, long-term complication of IPAA surgery and has a significant adverse impact on patients' quality of life. Treatment options for this disease are extremely limited. In the trial, patients received either 240 mg of an alicaforsen enema or a placebo nightly for six weeks. The participants will be monitored for up to six months after treatment. An enema is a
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