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Phase 3 trial to test potential pouchitis therapy
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Atlantic Healthcare has completed enrollment for a phase 3 trial of the efficacy and safety of alicaforsen, a potential treatment for pouchitis in patients with inflammatory bowel disease.
According to Brian Feagan, MD, professor of medicine at the University of Western Ontario and chief investigator of the study, pouchitis is a relatively rare disease that occurs in a subset of patients with IBD who undergo colectomy and receive an ileal pouch rather than an ostomy.
“The pouch is a nice surgical solution that allows patients to become continent and control their bowel,” Feagan told Healio Gastroenterology and Liver Disease. “Unfortunately, some patients, for reasons we don’t understand very well, develop chronic inflammation in the pouch, which is very strange given that the pouch is small bowel not colon. The original disease is inflammation in the colon, but now, they get it in the pouch.”
There are currently no approved therapies and limited treatment options are available for pouchitis, according to a press release. Atlantic Healthcare estimates that approximately 200,000 patients in the United States and Europe have the condition.
Feagan said alicaforsen targets inflammation in the lining of the bowel and uses “antisense” technology to neutralize the messenger RNA that signals for an immune response.
The phase 3 trial will take place at 40 centers across the U.S., Canada, Europe and Israel. Researchers will randomly assign patients one-to-one to receive 240 mg of alicaforsen or placebo, which patients will self-administer daily for 6 weeks. The drug is administered through an enema.
The primary endpoints of the trial are improvement in endoscopic healing and reduction in bowel frequency at week 10. Secondary endpoints of the study are improvement in other symptoms of the disease and quality of life. Researchers will also monitor patients for up to 6 months following therapy, according to the press release.
Atlantic Healthcare expects preliminary results in the first quarter of 2019. The FDA granted orphan drug status and a fast-track designation for alicaforsen, per the press release.
Although the condition is rare, Feagan said an approved drug would make a big difference for patients with pouchitis.
“For the patients, it’s nice to have a treatment that can be reimbursed that they know is effective, as opposed to how we’re treating the disease now, which is using drugs that are effective in other conditions without strong scientific evidence that those interventions are really effective in this disease,” he said. – by Alex Young
Disclosures: Feagan reports that he served as a consultant for Atlantic Healthcare.