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Clinical trial of Alicaforsen for patients with antibiotic refractory Pouchitis Atlantic Pharmaceuticals Ltd is alerting pouchitis patients to a new study. Patient recruitment for the study is now underway. There is currently no licensed product approved for the treatment of acute flares of pouchitis, although the use of antibiotics has become accepted as the norm for many patients. Unfortunately, over a period of time the efficacy of antibiotics declines and patients may fail to respond – they become “refractory” to treatment. Alicaforsen enema is a new product being investigated for the treatment of “antibiotic refractory” pouchitis. A Phase 3, randomised, double- blind, placebo-controlled parallel group study will enrol adult patients in approximately 40 sites across the US, Canada, Israel and Europe. Alicaforsen works to reduce the levels of ICAM-1, a protein in the body which is involved in inflammation. Patients that are experiencing an acute flare of pouchitis will be eligible for the study (full selection criteria below). Each patient will receive a 6 week course of treatment – alicaforsen enema (240mg) to be self-ministered at home, once night (before going to bed). Response to treatment will be based on the patient’s symptoms (collected by the patient, daily, on an electronic diary card), which include reduction in relative stool frequency. Further assessment will be done through endoscopy data, with patients requiring endoscopies at the start of the trial, and at week 6, and 10. Patients will return to the clinic for safety and efficacy assessments at week, 3, 6, 10, 18, 26. Some patients will receive placebo in the trial, but this will be in addition to their standard medication. All patients will be eligible for open-label alicaforsen post- trial, assuming they meet appropriate medical criteria. Eligibility 18 Years and Ages Eligible for Study: older Genders Eligible for Both Study: Accepts Healthy No Volunteers: Criteria Inclusion Criteria: 1. Written informed consent; 2. Male or female subjects, 18 years of age who have undergone an IPAA for UC 3. History of pouchitis 4. Overall PDAI score > 7 5. Must have Chronic Antibiotic Refractory Pouchitis Exclusion Criteria: 1. Lack of effective contraception 2. Women who are pregnant or breastfeeding; 3. Strong analgesia NSAID use 4. Change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 ASA), Oral steroids,, Immunosuppressant therapy. 5. Rectal products 6. Biological agents: Anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit. 7. All other agents targeted to pouchitis, including experimental agents, must have been discontinued at least 8 weeks prior to the Screening Visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer) 8. Anal sphincter dysfunction 9. Infections to cytomegalovirus or Clostridium difficile 10. Other GI pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses 11. Clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial In summary, you may be eligible if you: Are an adult, with a previous diagnosis of ulcerative colitis, leading to pouch surgery If you have subsequently developed pouchitis If you suffer a flare of pouchitis which can no longer be controlled by antibiotics For further information please go to: http://www.atlantichc.com/patientinfo.htm UK trial centres Nottingham Digestive Diseases Centre University Hospital Barts and the London University Hospital Coventry St Marks Hospital, Harrow University College Hospital, London Queen Elizabeth University Hospital, Birmingham Ethics approval Ethics approval has already been provided, in writing, to the UK lead investigator (Dr James Lindsay). The letter is date 30 December 2015. The reviewing committee was “London – Westminster Research Ethics Committee”..

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