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 monitored for up to six months or until they experience a flare. Patients’ quality of life is also being evaluated. The trial is being conducted at 40 centers in the United States, Canada, Europe, and Israel, with results expected in the second half of 2017. "This latest granted patent extends the family of intellectual proper
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