UK-based Atlantic Healthcare has started enrolling patients in a Phase III trial of alicaforsen enema to treat pouchitis, an inflammatory bowel disease (IBD).
The Phase III trial will be the largest ever conducted for pouchitis, for which there are currently no approved treatments.
A total of 138 patients are being enrolled at 40 clinical trial centres across the US, Canada, Europe and Israel, with results expected in the second half of next year.
The trial is designed to evaluate the safety and efficacy of alicaforsen enema in patients with active, chronic, antibiotic refractory pouchitis.
During the trial, patients will be given either 240mg alicaforsen enema or placebo, both of which will be self-administered every day for six weeks.
The company noted that the protocol, including the primary endpoints, has been agreed with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada.
Robarts Research Institute Clinical Trials director and chief investigator on the trial Brian Feagan said: "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.
"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, 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."
The trial's primary endpoints include the proportion of patient with endoscopic remission or a reduction in relative stool frequency at week ten.
Atlantic Healthcare CEO Toby Wilson Waterworth said: "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 II 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.
"This trial will assess the efficacy of alicaforsen in pouchitis patients who have failed to respond to first line antibiotic therapies."