Atlantic Healthcare plc announced that it is now enrolling patients in a Phase 3 clinical trial to assess alicaforsen enema for the treatment of inflammatory bowel disease (IBD) pouchitis. Pouchitis, the inflammation of the ileal pouch (an artificial rectum surgically created out of ileal gut tissue in patients who have undergone a colectomy), currently has no approved treatment medications.
Atlantic Healthcare is recruiting up to 138 patients with active, chronic, antibiotic refractory pouchitis. The randomized, placebo-controlled and double-blind Phase 3 efficacy and safety trial of alicaforsen enema — in a locally active topical formulation — will be conducted at 40 centers in the United States, Canada, Europe, and Israel. The company is expecting to report trial data in the second half of 2017.
All participants will be treated with 240 mg of alicaforsen enema or with a placebo, self-administered daily for a period of six weeks. The FDA (U.S.), EMA (Europe), and Health Canada all approved the trial protocol, which includes as primary endpoints the proportion of patients with endoscopic remission and the proportion with a reduction in relative stool frequency at week 10.
Patients will be asked to record every day their pouchitis-associated symptoms. At study entry and at weeks six and 10, patients will be examined through endoscopy and biopsy samples will be taken. All will be monitored for a period of six months or until they experience flare. The trial will also examine the patients’ quality of life.
“The management of ulcerative colitis and pouchitis continues to be a very important area of concern for gastroenterologists. This will be the most extensive clinical trial ever conducted in pouchitis,” said Professor Brian Feagan, director of Clinical Trials at Robarts Research Institute, and the study’s chief investigator, in a press release. “Alicaforsen is potentially one of the most promising new products in the field. Pouchitis is a disease with currently no approved therapies. Existing treatments include antibiotics, steroids and antibody biologics, therapies that these patients will have previously failed in treating their UC [ulcerative colitis], leading those patients to require surgery to remove the colon and form an ileal pouch. As such, alicaforsen has the potential to address an enormous unmet clinical need.”
Toby Wilson Waterworth, CEO of Atlantic Healthcare, added, “Alicaforsen offers patients a potential new alternative and, importantly, this is a new class of therapy. As a local topical treatment, alicaforsen has a highly attractive safety profile and provides the convenience of self-administration at home. In Phase 2 studies, alicaforsen was shown to provide patients in flare with a durable response lasting, on average, six months following a once-a-day six-week course of treatment.”
Alicaforsen is an anti-inflammatory, intercellular adhesion molecule (ICAM-1) inhibitor that acts by inhibiting key proteins, called ICAMs, that mediate inflammatory responses in tissues, including those in the gastrointestinal tract. Alicaforsen switches off the production of the protein ICAM-1 by binding to and degrading the mRNA that encodes it. It is intended that, in treating ulcerative colitis and pouchitis, alicaforsen will block the mechanism for local inflammation in the colon.
Atlantic Healthcare has worldwide exclusive rights to alicaforsen, which has been licensed from Ionis Pharmaceuticals, Inc., and patent and regulatory exclusivity until around 2030.