Atlantic Healthcare has completed enrollment for a Phase 3 trial evaluating the safety and efficacy of alicaforsen in patients with pouchitis, a frequent complication after surgery to treat different forms of inflammatory bowel disease (IBD).
IBD patients have increased production of ICAM-1 protein, which correlates with intestinal inflammation. Alicaforsen binds specifically to the human ICAM-1 messenger RNA, reducing the amount of ICAM-1 protein that is produced, thus helping to stop the disease-associated inflammation.
Launched in August 2015, the randomized, multicenter, double-blind, placebo-controlled trial (NCT02525523) is assessing the safety and efficacy of alicaforsen’s enema formulation in patients with pouchitis in active flare who have failed to effectively respond to therapy, or those who cannot take antibiotics.
Enrolled participants include Canadian, U.S., and European ulcerative colitis patients who had undergone ileal pouch-anal anastomosis (IPAA) surgery – a procedure used to restore gastrointestinal continuity after the surgical removal of the colon and rectum, with the construction of a pouch made from a loop of small intestine.
Pouchitis is the inflammation of the surgically created pouch. It is the most common, long-term complication of IPAA surgery and has a significant adverse impact on patients’ quality of life. Treatment options for this disease are extremely limited.
In the trial, patients received either 240 mg of an alicaforsen enema or a placebo nightly for six weeks. The participants will be monitored for up to six months after treatment.
An enema is a medical procedure used to introduce liquid into the large intestine through the rectum. In this case, the intervention’s purpose is to treat the inflammation of the surgically created pouch.
The trial’s primary goals are an improvement in endoscopic healing and a reduction in bowel frequency at week 10. Secondary goals include improving other pouchitis-related symptoms and the overall quality of life.
“I am pleased to see completion of enrollment of patients to this Phase 3 study providing the potential for the first and only approved treatment for pouchitis,” Brian Feagan, senior scientific director at Robarts Clinical Trials and chief investigator of the study, said in a news release. “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 U.S. and Europe, for which there remains a critical unmet clinical need.”
“We are pleased to have achieved this important milestone in our alicaforsen clinical development strategy and value creation for shareholders, and look forward to sharing preliminary results of the study early next year. We extend our gratitude to the patients who have participated in this study and to the clinical investigators and patient advocacy groups who share our commitment to improving the care and outcomes of patients with GI disorders,” said Toby Wilson Waterworth, CEO at Atlantic Healthcare.
Alicaforsen has U.S. Food and Drug Administration (FDA) fast-track designation and orphan drug status from the FDA and the European Medicines Agency for pouchitis treatment. In May 2017, Atlantic Healthcare initiated FDA rolling submission of its new drug application for alicaforsen in the treatment of pouchitis.
The pharmaceutical company plans to report the study’s preliminary findings by the first quarter of next year.
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