Atlantic HealthCare plc initiates Phase III study of alicaforsen enema to treat pouchitis.

Atlantic Healthcare plc, an international specialty pharma company focusing on gastrointestinal disorders, is pleased to announce that patient recruitment has commenced for a Phase III trial of its wholly-owned product alicaforsen enema to treat Inflammatory Bowel Disease (IBD) pouchitis. There are currently no approved drugs for pouchitis and this trial will be the largest ever conducted for the indication. Atlantic is recruiting 138 patients at 40 trial centres across the United States, Canada, Europe and Israel. Results are expected to be reported in H2 2017.

The trial is a randomised, double-blind, placebo-controlled, pivotal, Phase III safety and efficacy study of alicaforsen enema in patients with active, chronic, antibiotic refractory pouchitis. Patients will receive either 240mg alicaforsen enema or placebo, self-administered daily for six weeks. The protocol, including the primary endpoints, is agreed with the FDA, EMA, and Health Canada. The primary endpoints comprise the proportion of patients with endoscopic remission at week 10, and the proportion of patients with a reduction in relative stool frequency at week 10. Patients will record clinical symptoms associated with pouchitis daily, and will also undergo endoscopic examination of their pouch at the start of the trial and at weeks 6 and 10, with biopsy samples taken where possible. Patients will be monitored for six months or until they next flare, whichever is sooner. The trial will also assess Quality of Life.

Comment: Pouchitis is inflammation of the ileal pouch (an artificial rectum surgically created out of ileal gut tissue in patients who have undergone a colectomy), which is created in the management of patients with ulcerative colitis, indeterminate colitis, FAP, or, rarely, other colitides.

Comment: Clotrimazole gel from Aes Rx/Baxter/Baxalta is in Phase II trials for pouchitis .