US Patent Issued for Atlantic Healthcare’s Alicaforsen to Treat IBD Pouchitis

US Patent Issued for Atlantic Healthcare’s Alicaforsen to Treat IBD Pouchitis
A U.S. patent has been issued to Atlantic Healthcare's investigational drug alicaforsen for the treatment of inflammatory bowel disease (IBD). The patent (No. 9453221) extends the use of alicaforsen in IBD-related rectal stump inflammation and pain, and is part of the trans-Atlantic group’s strategy to broaden the clinical indications and formulations based on alicaforsen. The therapy candidate is being evaluated in a Phase 3 clinical trial for the treatment of IBD pouchitis, a nonspecific inflammatory condition in the ileal pouch reservoir (an artificial rectum surgically created out of ileal gut tissue in patients who have undergone a colectomy) for patients with ulcerative colitis (UC). There are currently no approved therapies for the condition. The placebo-controlled Phase 3 trial (NCT02525523) is evaluating the effectiveness and safety of alicaforsen in a topical formulation in up to 138 patients with IBD pounchitis. All participants are being treated with either with 240 mg of alicaforsen or a placebo, self-administered daily for six weeks. The trial is currently recruiting patients. The trial's primary endpoints include the number of patients with endoscopic remission and the number of patients with a reduction in relative stool frequency after 10 weeks. At the start of study and at weeks 6 and 10, all patients will undergo endoscopy examination and will have biopsy samples taken. Study participants will be monit
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