Atlantic Healthcare starts pivotal Phase 3 trial of Alicaforsen to treat Inflammatory Bowel Disease Pouchitis
Study of fast-tracked and orphan designated alicaforsen is the largest ever in pouchitis, and aims to confirm efficacy in antibiotic refractory patients
Atlantic Healthcare plc, an international specialty pharma company focusing on gastrointestinal disorders, is pleased to announce that patient recruitment has commenced for a Phase 3 trial of its wholly-owned product alicaforsen enema to treat Inflammatory Bowel Disease (IBD) pouchitis. There are currently no approved drugs for pouchitis and this trial will be the largest ever conducted for the indication. Atlantic is recruiting 138 patients at 40 trial centres across the United States, Canada, Europe and Israel. Results are expected to be reported in H2 2017.
The trial is a randomised, double-blind, placebo-controlled, pivotal, Phase 3 safety and efficacy study of alicaforsen enema in patients with active, chronic, antibiotic refractory pouchitis. Patients will receive either 240mg alicaforsen enema or placebo, self-administered daily for six weeks. The protocol, including the primary endpoints, is agreed with the FDA, EMA, and Health Canada.
Read the full article on reuters.com here.