Atlantic Healthcare has completed patient enrolment in a Phase III trial of alicaforsen to treat patients with IBD pouchitis.
The randomised, double-blind, placebo-controlled trial expects to evaluate the safety and efficacy of alicaforsenas in enema formulation.
The trial has enrolled patients who have previously undergone colectomy to remove the colon due to failure of drug therapy for ulcerative colitis (UC), and have then undergone ileal pouch-anal anastomosis (IPAA) surgery to create a new rectum.
Phase III trial chief investigator Brian Feagan said: “This is another important milestone in assessing the clinical value of alicaforsen in this setting, a rare disease believed to impact the lives of approximately 200,000 patients in the US and Europe, for which there remains a critical unmet clinical need.”
Under the trial, the patients were randomised one-to-one to receive 240mg of alicaforsen enema or placebo at 40 sites across the US, Canada, Europe and Israel.
The patients self-administered the prescribed doses of alicaforsen and placebo daily for six weeks.
The trial’s co-primary endpoints are improvement in endoscopic healing and reduction in bowel frequency at week ten, while its secondary endpoints include improvement in other symptoms of the disease and quality of life.
Patients in the trial are monitored for up to six months after treatment.
Atlantic plans to conclude the trial and report preliminary results by the first quarter of next year.
IBD pouchitiss is a rare and serious form of inflammatory bowel disease (IBD), which has limited treatment options.
There is currently no approved therapy available for the disease.