Our study is currently in Phase 3 and as a multi-centre, randomised, double-blind, placebo-controlled study to determine whether EPA-FFA can reduce the number of rectal polypectomies over the course of the two-year study (as an adjunct to appropriate endoscopic or surgical management) in subjects, aged 18-65 years, with a diagnosis of FAP and previous colectomy with ileo-rectal anastomosis.
Eligible subjects are defined as those diagnosed by a deleterious APC mutation, a previous colectomy with ileo-rectal anastomosis substantiating an intact rectum, subjects must also have ≤10 polyps, any polyps > 5mm in the rectum at screening will be removed where possible.
Patients will be staged following the Insight Polyposis Staging System (IPSS) that was developed at the 2011 meeting of the International Society for Gastrointestinal Hereditary Tumors (InSiGHT) in San Antonio, Texas, where a group of experts on FAP, many of whom are scientific advisors or investigators for this study, got together in order to develop an approach to FAP that would provide clinical trial primary endpoints of disease that would represent a clinical benefit.
204 patients will be randomised in a 1:1 ratio, to EPA-FFA (2g daily) or matching placebo. EPA or placebo will be supplied for up to 2 years and patients will undergo safety assessments at regular intervals and colonoscopy/endoscopy based on the stage at baseline.
The primary endpoint will be the ability of EPA-FFA to reduce the number of polypectomies across the two-year period, visits will occur at 6, 12 and 18 months with a follow up occurring at 25 months. Secondary endpoints will measure clinical disease progression and evaluate long term safety and tolerability of EPA-FFA.