ALFA^TM clinical trials

ALFA^TM is currently in a Phase 3 clinical trial to assess the efficacy and safety of eicosapentaenoic acid free fatty acid (EPA-FFA) for patients with familial adenomatous polyposis (FAP).

About FAP (Familial Adenomatous Polyposis)

FAP is a serious, life-threatening, genetic disorder and is characterized by the initial development of many tens to thousands of adenomas in the rectum and colon during the second decade of life. Because of the high numbers of adenomas in untreated cases close to 100% of persons affected will go on to develop colorectal cancer (CRC).

The objective of the clinical development programme is to evaluate the effect of eicosapentaenoic acid gastro-resistant capsules (2g/day) on polyp number and disease progression. The proposed benefit of reducing polyp number and disease progression is to reduce or delay subsequent clinical events such as polypectomy, endoscopic surveillance and surgery.

Decreasing polyp number and size would result in fewer total polypectomies and fewer large polypectomies, which would be expected to decrease the cumulative serious complication rate and have more long-term clinical benefits, which would be a positive impact on the timing and type of surgery and reduce the risk of colorectal cancer.

A safe and effective agent that prevents the development of polyps would be of significant benefit to FAP patients.

Our study

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.