Topical Treatment for Inflammatory Bowel Disease Pouchitis Starts Pivotal Phase 3 Trial, Now Enrolling Patients

Topical Treatment for Inflammatory Bowel Disease Pouchitis Starts Pivotal Phase 3 Trial, Now Enrolling Patients
Atlantic Healthcare plc announced that it is now enrolling patients in a Phase 3 clinical trial to assess alicaforsen enema for the treatment of inflammatory bowel disease (IBD) pouchitis. Pouchitis, the inflammation of the ileal pouch (an artificial rectum surgically created out of ileal gut tissue in patients who have undergone a colectomy), currently has no approved treatment medications. Atlantic Healthcare is recruiting up to 138 patients with active, chronic, antibiotic refractory pouchitis. The randomized, placebo-controlled and double-blind Phase 3 efficacy and safety trial of alicaforsen enema — in a locally active topical formulation — will be conducted at 40 centers in the United States, Canada, Europe, and Israel. The company is expecting to report trial data in the second half of 2017. All participants will be treated with 240 mg of  alicaforsen enema or with a placebo, self-administered daily for a period of six weeks. The FDA (U.S.), EMA (Europe), and Health Canada all approved the trial protocol, which includes as primary endpoints the proportion of patients with endoscopic remission and the proportion with a reduction in relative stool frequency at week 10. Patients will be asked to record every day their pouchitis-associated symptoms. At study entry and at weeks six and 10, patients will be examined through endoscopy and biopsy samples will be taken. All will be monitored for a period of six months or until they experience flare. The trial will also examine the patients' quality of life. “The management of ulcerative colitis and pouchitis continues to be a very important area of concern for gastroenterologists. This will be
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