Here are five things to know.
1. IBD pouchitis is a severe form of irritable bowel disease for which there is no approved therapy. It is believed to impact approximately 200,000 people in the U.S. and Europe.
2. The randomized, double-blind, placebo-controlled study is designed to assess the safety and efficacy of alicaforsen as an enema formulation in patients with pouchitis in active flare who have not adequately responded to a course of antibiotics, or who are contraindicated for antibiotics.
3. The study participants had previously undergone colectomy due to the failure of drug therapy for ulcerative colitis, and then underwent ileal pouch-anal anastomosis surgery to create a new rectum.
4. Atlantic Healthcare anticipates completing the Phase 3 study and reporting preliminary results in the first quarter of 2019.
5. In May 2017, the company initiated a rolling submission of its New Drug Application to the FDA for alicaforsen to treat pouchitis. The FDA and the European Medicines Agency granted alicaforsen orphan drug status, and it received FDA Fast-Track designation.
Here is more information about the study.
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